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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-508057-19-00 | Registry Identifier | CTIS (EU) |
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The purpose of this study is to measure the efficacy and safety of T-DXd with rilvegostomig or T-DXd monotherapy compared with gemcitabine plus cisplatin and durvalumab in patients with advanced treatment naïve HER2-expressing BTC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trastuzumab deruxtecan + rilvegostomig | Experimental | Trastuzumab deruxtecan (T-DXd; DS-8201a) in combination with rilvegostomig arm |
|
| Trastuzumab deruxtecan | Experimental | Trastuzumab deruxtecan (T-DXd; DS-8201a) arm |
|
| Standard of Care | Active Comparator | Gemcitabine and cisplatin in combination with durvalumab arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine | Drug | Standard of care chemotherapy by intravenous infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Run In: To evaluate the safety and tolerability of T-DXd with rilvegostomig | Safety and tolerability will be evaluated by the proportion of treated patients with occurrence of AEs, SAEs and AESIs, as assessed by CTCAE v5.0. | Until all patients have completed at least 1 full Cycle (each cycle is 21 days) |
| Randomized Portion: To evaluate the efficacy of T-DXd with rilvegostomig vs Standard of Care (SoC) in terms of Overall Survival in the FAS (HER2 IHC 3+) population | Overall survival (OS) in FAS (HER2 IHC 3+) population OS is defined as time from randomization date until the date of death due to any cause. The comparison will include all randomized patients, regardless of whether the patient withdraws from therapy or receives another anticancer therapy. The measure of interest is the hazard ratio of OS. | From date of treatment randomization until the date of death from any cause (estimated to be assessed up to 50 months after first subject randomized) |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the efficacy of T-DXd with rilvegostomig vs Standard of Care in terms of Overall Survival in the FAS (HER2 IHC 3+/2+) population | Overall Survival (OS) in FAS (HER2 IHC 3+/2+) population. OS definition as above. | From date of randomization until the date of death from any cause (estimated to be assessed up to 50 months after first subject randomized) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical Study Information Center | Contact | 1-877-240-9479 | information.center@astrazeneca.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Recruiting | Scottsdale | Arizona | 85259 | United States | |
| Research Site |
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
"Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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This is an open-label, Sponsor-blinded study. To maintain the integrity of the study, Sponsor personnel directly involved in study conduct will not undertake or have access to efficacy data aggregated by treatment group prior to final data readout for the primary endpoint.
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| Cisplatin |
| Drug |
Standard of care chemotherapy by intravenous infusion |
|
| Durvalumab | Drug | Standard of care immunotherapy by intravenous infusion |
|
| Trastuzumab deruxtecan | Drug | Experimental therapy by intravenous infusion |
|
|
| Rilvegostomig | Drug | Experimental therapy by intravenous infusion |
|
| To evaluate the efficacy of T-DXd monotherapy vs Standard of Care in terms of Overall Survival in the FAS (HER2 IHC 3+) population | Overall Survival (OS) in FAS (HER2 IHC 3+) population. OS definition as above. | From date of randomization until the date of death from any cause (estimated to be assessed up to 50 months after first subject randomized) |
| To evaluate the efficacy of T-DXd monotherapy vs Standard of Care in terms of Overall Survival in the FAS (HER2 IHC 3+/2+) population | Overall Survival (OS) in FAS (HER2 IHC 3+/2+) population. OS definition as above. | From date of randomization until the date of death from any cause (estimated to be assessed up to 50 months after first subject randomized) |
| To further evaluate efficacy of T-DXd with rilvegostomig vs Standard of Care in terms of Progression Free Survival in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations | Progression free survival (PFS) in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations. PFS is defined as time from randomization until progression per RECIST v1.1, or death due to any cause. The analysis will include all randomized patients, regardless of whether the patient withdraws from randomized therapy, receives another anticancer therapy or clinically progresses prior to RECIST v1.1 progression. The measure of interest is the hazard ratio of PFS. | From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs first (estimated to be assessed up to 50 months) |
| To further evaluate efficacy of T-DXd monotherapy vs Standard of Care in terms of Progression Free Survival in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations | Progression free survival (PFS) in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations. PFS is defined as time from randomization until progression per RECIST v1.1, or death due to any cause. The analysis will include all randomized patients, regardless of whether the patient withdraws from randomized therapy, receives another anticancer therapy or clinically progresses prior to RECIST v1.1 progression. The measure of interest is the hazard ratio of PFS. | From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs first (estimated to be assessed up to 50 months) |
| To further evaluate the efficacy of T-DXd with rilvegostomig vs Standrad of Care in terms of objective response rate in the FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations | Objective response rate (ORR) in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations. ORR is defined as the proportion of patients who achieved CR or PR per RECIST 1.1, as assessed by the investigator. The analysis will include objective response data for all randomized patients from randomization until progression, or up to the last evaluable assessment in the absence of progression. Patients who go off-treatment without a response or progression and then respond while receiving a subsequent therapy will not be included as responders in the ORR calculation. The measure of interest is the risk difference of ORR. | From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs first (estimated to be assessed up to 50 months) |
| To further evaluate the efficacy of T-DXd monotherapy vs Standrad of Care in terms of objective response rate in the FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations | Objective response rate (ORR) in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations. ORR is defined as the proportion of patients who achieved CR or PR per RECIST 1.1, as assessed by the investigator. The analysis will include objective response data for all randomized patients from randomization until progression, or up to the last evaluable assessment in the absence of progression. Patients who go off-treatment without a response or progression and then respond while receiving a subsequent therapy will not be included as responders in the ORR calculation. The measure of interest is the risk difference of ORR. | From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs first (estimated to be assessed up to 50 months) |
| To further evaluate efficacy of T-DXd with rilvegostomig vs Standard if Care in terms of duration of response in patients with HER2-expressing BTC in the FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations | Duration of response (DoR) in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations. DoR will be defined as the time from the date of first documented response until date of documented progression per RECIST v1.1, or death due to any cause. The analysis will include all randomized patients who have a response, regardless of whether the patient withdraws from randomized therapy, receives another anti-cancer therapy or clinically progresses prior to RECIST v1.1 progression. The measure of interest is the median DoR. | From the date of first documented response until date of documented progression or death due to any cause, whichever occurs first (estimated up to 50 months) |
| To further evaluate efficacy of T-DXd monotherapy vs Standard if Care in terms of duration of response in patients with HER2-expressing BTC in the FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations | Duration of response (DoR) in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations. DoR will be defined as the time from the date of first documented response until date of documented progression per RECIST v1.1, or death due to any cause. The analysis will include all randomized patients who have a response, regardless of whether the patient withdraws from randomized therapy, receives another anti-cancer therapy or clinically progresses prior to RECIST v1.1 progression. The measure of interest is the median DoR. | From the date of first documented response until date of documented progression or death due to any cause, whichever occurs first (estimated up to 50 months) |
| To further evaluate the efficacy of T-DXd with rilvegostomig versus T-DXd monotherapy in terms of Overall survival in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations. | Overall survival (OS) in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations. OS is defined as time from randomization date until the date of death due to any cause. The comparison will include all randomized patients, regardless of whether the patient withdraws from therapy or receives another anticancer therapy. The measure of interest is the hazard ratio of OS. | From date of randomization until the date of death from any cause (estimated to be assessed up to 50 months after first subject randomized) |
| To further evaluate the efficacy of T-DXd with rilvegostomig versus T-DXd monotherapy in terms of PFS in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations | Progression free survival (PFS) in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations. PFS is defined as time from randomization until progression per RECIST v1.1, or death due to any cause. The analysis will include all randomized patients, regardless of whether the patient withdraws from randomized therapy, receives another anticancer therapy or clinically progresses prior to RECIST v1.1 progression. The measure of interest is the hazard ratio of PFS. | From the date of randomisation until progression or death due to any cause, whichever occurs first (estimated up to 50 months) |
| To further evaluate the efficacy of T-DXd with rilvegostomig versus T-DXd monotherapy in terms of Duration of response in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations | Duration of response (DoR) in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations. DoR will be defined as the time from the date of first documented response until date of documented progression per RECIST v1.1, or death due to any cause. The analysis will include all randomized patients who have a response, regardless of whether the patient withdraws from randomized therapy, receives another anti-cancer therapy or clinically progresses prior to RECIST v1.1 progression. The measure of interest is the median DoR. | From the date of first response until progression or death due to any cause, whichever occurs first (estimated up to 50 months) |
| To further evaluate the efficacy of T-DXd with rilvegostomig versus T-DXd monotherapy in terms of Objective response rate in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations | Objective response rate (ORR) in FAS (HER2 IHC 3+) and FAS (HER2 IHC 3+/2+) populations. ORR is defined as the proportion of patients who achieved CR or PR per RECIST 1.1, as assessed by the investigator. The analysis will include objective response data for all randomized patients from randomization until progression, or up to the last evaluable assessment in the absence of progression. Patients who go off-treatment without a response or progression and then respond while receiving a subsequent therapy will not be included as responders in the ORR calculation. The measure of interest is the risk difference of ORR. | From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs first (estimated to be assessed up to 50 months) |
| To assess the safety and tolerability of T-DXd with rilvegostomig vs Standard of Care | Safety and tolerability will be evaluated by the proportion of treated patients with occurrence of AEs, SAEs and AESIs, as assessed by CTCAE v5.0. | From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs first (estimated to be assessed up to 50 months) |
| To assess the safety and tolerability of T-DXd monotherapy vs Standard of Care | Safety and tolerability will be evaluated by the proportion of treated patients with occurrence of AEs, SAEs and AESIs, as assessed by CTCAE v5.0. | From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs first (estimated to be assessed up to 50 months) |
| To describe patient-reported tolerability of T-DXd with rilvegostomig in comparison to Standard of Care based on a summary of symptomatic AEs | Patient-reported tolerability will be described using the Symptomatic adverse events: Descriptive summary of the proportion of patients reporting symptomatic AEs while on treatment using items from the EORTC Item Library (on EORTC IL form 322). | Until End of Study (estimated up to 50 months) |
| To describe patient-reported tolerability of T-DXd monotherapy in comparison to SoC based on a summary of symptomatic AEs | Patient-reported tolerability will be described using the Symptomatic adverse events: Descriptive summary of the proportion of patients reporting symptomatic AEs while on treatment using items from the EORTC Item Library (on EORTC IL form 322) | Until End of Study (estimated up to 50 months) |
| To describe patient-reported tolerability of T-DXd with rilvegostomig in comparison to T-DXd monotherapy based on a summary of symptomatic AEs | Patient-reported tolerability will be described using the Symptomatic adverse events: Descriptive summary of the proportion of patients reporting symptomatic AEs while on treatment using items from the EORTC Item Library (on EORTC IL form 322). | Until End of Study (estimated up to 50 months) |
| To assess time to deterioration in physical functioning in patients treated with T-DXd with rilvegostomig vs Standard of Care | Time to deterioration (TTD) in physical function as measured by the PROMIS Short Form v2.0 - Physical Function 8c - TTD is defined as time from the date of randomization to the date of deterioration. Deterioration is defined as the change from baseline that reaches a clinically meaningful deterioration threshold. - The measure of interest is the HR of TTD in physical function. The analysis will include all randomized patients as randomized. | Until End of Study (estimated up to 50 months) |
| To assess time to deterioration in physical functioning in patients treated with T-DXd monotherapy vs Standard of care | Time to deterioration (TTD) in physical function as measured by the PROMIS Short Form v2.0 - Physical Function 8c - TTD is defined as time from the date of randomization to the date of deterioration. Deterioration is defined as the change from baseline that reaches a clinically meaningful deterioration threshold. - The measure of interest is the HR of TTD in physical function. The analysis will include all randomized patients as randomized. | Until End of Study (estimated up to 50 months) |
| To assess time to deterioration in physical functioning in patients treated with T-DXd with rilvegostomig vs T-DXd monotherapy | Time to deterioration (TTD) in physical function as measured by the PROMIS Short Form v2.0 - Physical Function 8c - TTD is defined as time from the date of randomization to the date of deterioration. Deterioration is defined as the change from baseline that reaches a clinically meaningful deterioration threshold. - The measure of interest is the HR of TTD in physical function. The analysis will include all randomized patients as randomized. | Until End of Study (estimated up to 50 months) |
| To assess the pharmacokinetics of T-DXd, total anti- HER2 antibody, DXd and rilvegostomig in serum | Descriptive analysis of serum concentration of T-DXd, total anti-HER2 antibody, DXd and rilvegostomig in all applicable arms. | From the time of informed consent until 90 days after the last dose of T-DXd and rilvegostomig |
| To investigate the immunogenicity of T-DXd and of rilvegostomig | Descriptive summary of presence of ADAs for T-DXd and rilvegostomig in all applicable arms. | From the time of informed consent until 30 and 90 days after the last dose of T-DXd and rilvegostomig, respectively |
| To describe patient-reported tolerability of T-DXd with rilvegostomig in comparison to Standard of Care based on overall side-effect bother | Patient-reported tolerability will be described using the Overall side-effect bother that will be mesured using PGI-TT | Until End of Study (estimated up to 50 months) |
| To describe patient-reported tolerability of T-DXd monotherapy in comparison to SoC based on overall side-effect bother | Patient-reported tolerability will be described using the Overall side-effect bother that will be assessed will be mesured using PGI-TT | Until End of Study (estimated up to 50 months) |
| To assess the safety and tolerability of T-DXd with rilvegostomig vs T-DXd monotherapy | Safety and tolerability will be evaluated by the proportion of treated patients with occurrence of AEs, SAEs and AESIs, as assessed by CTCAE v5.0. | From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs first (estimated to be assessed up to 50 months) |
| To describe patient-reported tolerability of T-DXd with rilvegostmog in comparison to T-DXd monotherapy based on overall side-effect bother | Patient-reported tolerability will be described using the Overall side-effect bother that will be assessed will be mesured using PGI-TT. | Until End of Study (estimated up to 50 months) |
| Withdrawn |
| Tucson |
| Arizona |
| 85704 |
| United States |
| Research Site | Recruiting | Tucson | Arizona | 85719 | United States |
| Research Site | Recruiting | Fullerton | California | 92835 | United States |
| Research Site | Recruiting | La Jolla | California | 92093 | United States |
| Research Site | Suspended | Los Alamitos | California | 90720 | United States |
| Research Site | Recruiting | Los Angeles | California | 90017 | United States |
| Research Site | Recruiting | Los Angeles | California | 90089 | United States |
| Research Site | Recruiting | San Francisco | California | 94143 | United States |
| Research Site | Not yet recruiting | Walnut Creek | California | 94598 | United States |
| Research Site | Not yet recruiting | Washington D.C. | District of Columbia | 20007 | United States |
| Research Site | Recruiting | Fort Myers | Florida | 33901 | United States |
| Research Site | Recruiting | Jacksonville | Florida | 32224 | United States |
| Research Site | Recruiting | St. Petersburg | Florida | 33705 | United States |
| Research Site | Not yet recruiting | Tampa | Florida | 33606 | United States |
| Research Site | Recruiting | West Palm Beach | Florida | 33401 | United States |
| Research Site | Recruiting | Atlanta | Georgia | 30309 | United States |
| Research Site | Withdrawn | Coeur d'Alene | Idaho | 83814 | United States |
| Research Site | Recruiting | Chicago | Illinois | 60612 | United States |
| Research Site | Recruiting | Niles | Illinois | 60714 | United States |
| Research Site | Recruiting | Towson | Maryland | 21204 | United States |
| Research Site | Withdrawn | Boston | Massachusetts | 02215 | United States |
| Research Site | Withdrawn | Worcester | Massachusetts | 01655 | United States |
| Research Site | Withdrawn | Detroit | Michigan | 48202 | United States |
| Research Site | Recruiting | Grand Rapids | Michigan | 49503 | United States |
| Research Site | Recruiting | Rochester | Minnesota | 55905 | United States |
| Research Site | Recruiting | Kansas City | Missouri | 64132 | United States |
| Research Site | Recruiting | St Louis | Missouri | 63110 | United States |
| Research Site | Withdrawn | Albuquerque | New Mexico | 87102 | United States |
| Research Site | Withdrawn | New York | New York | 10032 | United States |
| Research Site | Recruiting | White Plains | New York | 10601 | United States |
| Research Site | Suspended | Cleveland | Ohio | 44111 | United States |
| Research Site | Suspended | Cleveland | Ohio | 44124 | United States |
| Research Site | Recruiting | Cleveland | Ohio | 44195 | United States |
| Research Site | Recruiting | Columbus | Ohio | 43210 | United States |
| Research Site | Not yet recruiting | Pittsburgh | Pennsylvania | 15232 | United States |
| Research Site | Recruiting | Greenville | South Carolina | 29605 | United States |
| Research Site | Withdrawn | Nashville | Tennessee | 37203 | United States |
| Research Site | Withdrawn | Austin | Texas | 78705 | United States |
| Research Site | Recruiting | Dallas | Texas | 75246 | United States |
| Research Site | Withdrawn | Fort Worth | Texas | 76104 | United States |
| Research Site | Recruiting | Fort Worth | Texas | 76104 | United States |
| Research Site | Recruiting | Houston | Texas | 77030 | United States |
| Research Site | Withdrawn | Pearland | Texas | 77584 | United States |
| Research Site | Withdrawn | San Antonio | Texas | 78217 | United States |
| Research Site | Withdrawn | San Antonio | Texas | 78258 | United States |
| Research Site | Recruiting | Fairfax | Virginia | 22031 | United States |
| Research Site | Withdrawn | Fairfax | Virginia | 22031 | United States |
| Research Site | Recruiting | Chermside | 4032 | Australia |
| Research Site | Recruiting | Clayton | 3168 | Australia |
| Research Site | Recruiting | Concord | 2139 | Australia |
| Research Site | Recruiting | Nedlands | 6009 | Australia |
| Research Site | Recruiting | Graz | 8036 | Austria |
| Research Site | Recruiting | Linz | 4010 | Austria |
| Research Site | Not yet recruiting | Salzburg | 5020 | Austria |
| Research Site | Recruiting | Vienna | 1090 | Austria |
| Research Site | Not yet recruiting | Wiener Neustadt | 2700 | Austria |
| Research Site | Recruiting | Anderlecht | 1070 | Belgium |
| Research Site | Recruiting | Edegem | 2650 | Belgium |
| Research Site | Recruiting | Ghent | 9000 | Belgium |
| Research Site | Recruiting | Leuven | 3000 | Belgium |
| Research Site | Recruiting | Liège | 4000 | Belgium |
| Research Site | Recruiting | Roeselare | 8800 | Belgium |
| Research Site | Recruiting | Natal | 59012-300 | Brazil |
| Research Site | Recruiting | Porto Alegre | 90035-000 | Brazil |
| Research Site | Recruiting | Porto Alegre | 91350-200 | Brazil |
| Research Site | Recruiting | Santa Maria | 97015-450 | Brazil |
| Research Site | Recruiting | São Paulo | 01246-000 | Brazil |
| Research Site | Recruiting | São Paulo | 05651-901 | Brazil |
| Research Site | Recruiting | Vitória | 29043-272 | Brazil |
| Research Site | Recruiting | Edmonton | Alberta | T6G 1Z2 | Canada |
| Research Site | Recruiting | Halifax | Nova Scotia | B3H 1V7 | Canada |
| Research Site | Recruiting | Brampton | Ontario | L6R 3J7 | Canada |
| Research Site | Recruiting | Toronto | Ontario | M5G 2M9 | Canada |
| Research Site | Recruiting | Montreal | Quebec | H3A 1A1 | Canada |
| Research Site | Recruiting | Beijing | 100020 | China |
| Research Site | Withdrawn | Beijing | 100021 | China |
| Research Site | Recruiting | Beijing | 100034 | China |
| Research Site | Recruiting | Beijing | 100142 | China |
| Research Site | Recruiting | Beijing | China |
| Research Site | Recruiting | Bengbu | 233004 | China |
| Research Site | Recruiting | Changchun | 130021 | China |
| Research Site | Recruiting | Changde | 415000 | China |
| Research Site | Recruiting | Changsha | 410005 | China |
| Research Site | Recruiting | Changsha | 410013 | China |
| Research Site | Recruiting | Chengdu | 610041 | China |
| Research Site | Recruiting | Chengdu | 610078 | China |
| Research Site | Withdrawn | Chongqing | 400030 | China |
| Research Site | Recruiting | Fuzhou | 350007 | China |
| Research Site | Recruiting | Guangzhou | 510080 | China |
| Research Site | Recruiting | Guangzhou | 510515 | China |
| Research Site | Recruiting | Guiyang | 550044 | China |
| Research Site | Recruiting | Hangzhou | 310016 | China |
| Research Site | Terminated | Harbin | 150081 | China |
| Research Site | Recruiting | Hefei | 230001 | China |
| Research Site | Recruiting | Hefei | 230601 | China |
| Research Site | Recruiting | Jinan | 250117 | China |
| Research Site | Recruiting | Kunming | 650101 | China |
| Research Site | Recruiting | Linyi | 276000 | China |
| Research Site | Recruiting | Luoyang | 471000 | China |
| Research Site | Recruiting | Nanchang | 330029 | China |
| Research Site | Recruiting | Nanjing | 2100008 | China |
| Research Site | Recruiting | Nanning | 530021 | China |
| Research Site | Recruiting | Nantong | 226001 | China |
| Research Site | Not yet recruiting | Shanghai | 200001 | China |
| Research Site | Withdrawn | Shanghai | 201107 | China |
| Research Site | Recruiting | Shanghai | 201114 | China |
| Research Site | Recruiting | Shenyang | 110004 | China |
| Research Site | Not yet recruiting | Shenzhen | 518116 | China |
| Research Site | Recruiting | Tianjin | 300060 | China |
| Research Site | Recruiting | Weifang | 261000 | China |
| Research Site | Recruiting | Wenzhou | 325035 | China |
| Research Site | Recruiting | Wuhan | 430079 | China |
| Research Site | Recruiting | Xi'an | 710061 | China |
| Research Site | Recruiting | Zhengzhou | 450008 | China |
| Research Site | Recruiting | Zhengzhou | 450052 | China |
| Research Site | Withdrawn | Brno | 625 00 | Czechia |
| Research Site | Recruiting | Brno | 656 53 | Czechia |
| Research Site | Recruiting | Hradec Králové | 500 05 | Czechia |
| Research Site | Recruiting | Olomouc | 77900 | Czechia |
| Research Site | Recruiting | Prague | 100 34 | Czechia |
| Research Site | Recruiting | Prague | 15006 | Czechia |
| Research Site | Recruiting | Brest | 29609 | France |
| Research Site | Recruiting | Clichy | 92118 | France |
| Research Site | Not yet recruiting | Dijon | 21079 | France |
| Research Site | Recruiting | Lille | 59037 | France |
| Research Site | Recruiting | Lyon | 69008 | France |
| Research Site | Recruiting | Lyon | 69373 | France |
| Research Site | Recruiting | Marseille | 13008 | France |
| Research Site | Recruiting | Montpellier | 34295 | France |
| Research Site | Recruiting | Pessac | 33604 | France |
| Research Site | Recruiting | Villejuif | 94800 | France |
| Research Site | Recruiting | Berlin | 13353 | Germany |
| Research Site | Recruiting | Bonn | 53127 | Germany |
| Research Site | Recruiting | Cologne | 50937 | Germany |
| Research Site | Recruiting | Dresden | 01370 | Germany |
| Research Site | Recruiting | Frankfurt | 60488 | Germany |
| Research Site | Recruiting | Freiburg im Breisgau | 79106 | Germany |
| Research Site | Recruiting | Göttingen | 37075 | Germany |
| Research Site | Recruiting | Hamburg | 22763 | Germany |
| Research Site | Recruiting | Leipzig | 4103 | Germany |
| Research Site | Recruiting | Lübeck | 23538 | Germany |
| Research Site | Recruiting | München | 81377, DE | Germany |
| Research Site | Recruiting | Ulm | 89081 | Germany |
| Research Site | Recruiting | Würzburg | 97080 | Germany |
| Research Site | Recruiting | Hong Kong | 999077 | Hong Kong |
| Research Site | Recruiting | Shatin | 00000 | Hong Kong |
| Research Site | Recruiting | Dehradun | 248016 | India |
| Research Site | Recruiting | Delhi | 110029 | India |
| Research Site | Recruiting | Delhi | 110088 | India |
| Research Site | Recruiting | Kanpur | 208001 | India |
| Research Site | Withdrawn | Kolkata | 700054 | India |
| Research Site | Recruiting | Kolkata | 700094 | India |
| Research Site | Recruiting | Mumbai | 400012 | India |
| Research Site | Recruiting | Vadodara | 391760 | India |
| Research Site | Withdrawn | Varanasi | 221005 | India |
| Research Site | Recruiting | Florence | 50134 | Italy |
| Research Site | Recruiting | Milan | 20132 | Italy |
| Research Site | Recruiting | Milan | 20162 | Italy |
| Research Site | Recruiting | Naples | 80128 | Italy |
| Research Site | Recruiting | Naples | 80131 | Italy |
| Research Site | Recruiting | Padova | 35128 | Italy |
| Research Site | Recruiting | Roma | 00133 | Italy |
| Research Site | Recruiting | Rozzano | 20089 | Italy |
| Research Site | Recruiting | Tricase | 73039 | Italy |
| Research Site | Recruiting | Bunkyō City | 113-8431 | Japan |
| Research Site | Recruiting | Bunkyō City | 113-8603 | Japan |
| Research Site | Recruiting | Bunkyō City | 113-8677 | Japan |
| Research Site | Recruiting | Chiba | 260-0877 | Japan |
| Research Site | Recruiting | Fukuyama-shi | 721-8511 | Japan |
| Research Site | Recruiting | Hirakata-shi | 573-1191 | Japan |
| Research Site | Recruiting | Hiroshima | 734-8551 | Japan |
| Research Site | Recruiting | Kanazawa | 920-8641 | Japan |
| Research Site | Recruiting | Kashiwa | 227-8577 | Japan |
| Research Site | Recruiting | Kawasaki-shi | 216-8511 | Japan |
| Research Site | Recruiting | Kita-gun | 761-0793 | Japan |
| Research Site | Recruiting | Kitaadachi-gun | 362-0806 | Japan |
| Research Site | Recruiting | Kōtoku | 135-8550 | Japan |
| Research Site | Recruiting | Kumamoto | 860-8556 | Japan |
| Research Site | Recruiting | Kyoto | 606-8507 | Japan |
| Research Site | Recruiting | Maebashi | 371-8511 | Japan |
| Research Site | Recruiting | Mitaka-shi | 181-8611 | Japan |
| Research Site | Recruiting | Nagoya | 464-8681 | Japan |
| Research Site | Recruiting | Nagoya | 466-8560 | Japan |
| Research Site | Recruiting | Osaka | 541-8567 | Japan |
| Research Site | Recruiting | Osaka | 545-8586 | Japan |
| Research Site | Recruiting | Sakaishi | 591-8025 | Japan |
| Research Site | Recruiting | Sapporo | 060-8543 | Japan |
| Research Site | Recruiting | Sendai | 980-8574 | Japan |
| Research Site | Recruiting | Shinjuku-ku | 160-8582 | Japan |
| Research Site | Recruiting | Suita | 565-0871 | Japan |
| Research Site | Recruiting | Sunto-gun | 411-8777 | Japan |
| Research Site | Recruiting | Ube-shi | 755-8505 | Japan |
| Research Site | Recruiting | Wakayama | 641-8510 | Japan |
| Research Site | Recruiting | Yokohama | 241-8515 | Japan |
| Research Site | Recruiting | George Town | 10990 | Malaysia |
| Research Site | Recruiting | Johor Bahru | 81100 | Malaysia |
| Research Site | Recruiting | Kuala Lumpur | 50586 | Malaysia |
| Research Site | Recruiting | Kuala Lumpur | 59100 | Malaysia |
| Research Site | Recruiting | Kuching | 93586 | Malaysia |
| Research Site | Withdrawn | Rotterdam | 3015 GD | Netherlands |
| Research Site | Not yet recruiting | Cebu City | 6000 | Philippines |
| Research Site | Not yet recruiting | Makati | 1229 | Philippines |
| Research Site | Not yet recruiting | Pasig | 1605 | Philippines |
| Research Site | Recruiting | Quezon City | 1112 | Philippines |
| Research Site | Recruiting | Bialystok | 15-027 | Poland |
| Research Site | Recruiting | Katowice | 40-514 | Poland |
| Research Site | Recruiting | Krakow | 31-501 | Poland |
| Research Site | Recruiting | Lublin | 20-080 | Poland |
| Research Site | Recruiting | Warsaw | 02-034 | Poland |
| Research Site | Withdrawn | Wroclaw | 50-556 | Poland |
| Research Site | Recruiting | Dammam | 31444 | Saudi Arabia |
| Research Site | Recruiting | Riyadh | 11426 | Saudi Arabia |
| Research Site | Not yet recruiting | Riyadh | 11525 | Saudi Arabia |
| Research Site | Recruiting | Riyadh | 12713 | Saudi Arabia |
| Research Site | Not yet recruiting | Banská Bystrica | 974 01 | Slovakia |
| Research Site | Recruiting | Bratislava | 833 10 | Slovakia |
| Research Site | Recruiting | Košice | 041 91 | Slovakia |
| Research Site | Recruiting | Martin | 036 59 | Slovakia |
| Research Site | Recruiting | Trnava | 917 75 | Slovakia |
| Research Site | Recruiting | Busan | 48108 | South Korea |
| Research Site | Recruiting | Gyeonggi-do | 13620 | South Korea |
| Research Site | Recruiting | Hwasun-gun | 58128 | South Korea |
| Research Site | Recruiting | Seongnam-si | 13496 | South Korea |
| Research Site | Recruiting | Seoul | 03080 | South Korea |
| Research Site | Recruiting | Seoul | 05505 | South Korea |
| Research Site | Recruiting | Seoul | 06351 | South Korea |
| Research Site | Recruiting | Seoul | 06591 | South Korea |
| Research Site | Recruiting | Seoul | 120-752 | South Korea |
| Research Site | Recruiting | Barcelona | 08035 | Spain |
| Research Site | Recruiting | Madrid | 28007 | Spain |
| Research Site | Recruiting | Madrid | 28040 | Spain |
| Research Site | Recruiting | Madrid | 28041 | Spain |
| Research Site | Recruiting | Málaga | 29010 | Spain |
| Research Site | Recruiting | Santander | 39008 | Spain |
| Research Site | Recruiting | Kaohsiung City | 00807 | Taiwan |
| Research Site | Recruiting | Kaohsiung City | 82445 | Taiwan |
| Research Site | Recruiting | Kaohsiung City | 833 | Taiwan |
| Research Site | Recruiting | Taichung | 40447 | Taiwan |
| Research Site | Recruiting | Taichung | 407219 | Taiwan |
| Research Site | Recruiting | Taipei | 10002 | Taiwan |
| Research Site | Recruiting | Taipei | 112 | Taiwan |
| Research Site | Recruiting | Taoyuan | 333 | Taiwan |
| Research Site | Recruiting | Bangkok | 10400 | Thailand |
| Research Site | Recruiting | Hat Yai | 90110 | Thailand |
| Research Site | Recruiting | Khon Kaen | 40002 | Thailand |
| Research Site | Recruiting | Muang | 50200 | Thailand |
| Research Site | Recruiting | Mueang | 47000 | Thailand |
| Research Site | Recruiting | Naimuang | 30000 | Thailand |
| Research Site | Recruiting | Ongkharak | 26120 | Thailand |
| Research Site | Recruiting | Si Sa Ket | 33000 | Thailand |
| Research Site | Recruiting | Altındağ | 06230 | Turkey (Türkiye) |
| Research Site | Recruiting | Antalya | 07100 | Turkey (Türkiye) |
| Research Site | Recruiting | Istanbul | 34218 | Turkey (Türkiye) |
| Research Site | Recruiting | Izmir | 35340 | Turkey (Türkiye) |
| Research Site | Recruiting | Mezitli | 33200 | Turkey (Türkiye) |
| Research Site | Recruiting | Yakutiye | 25040 | Turkey (Türkiye) |
| Research Site | Not yet recruiting | Birmingham | B15 2GW | United Kingdom |
| Research Site | Recruiting | Dundee | DD1 9SY | United Kingdom |
| Research Site | Recruiting | Glasgow | G12 0YN | United Kingdom |
| Research Site | Recruiting | Greater London | SW3 6JJ | United Kingdom |
| Research Site | Not yet recruiting | Leeds | LS9 7TF | United Kingdom |
| Research Site | Recruiting | London | EC1A 7BE | United Kingdom |
| Research Site | Recruiting | Hanoi | 100000 | Vietnam |
| Research Site | Recruiting | Ho Chi Minh City | 700000 | Vietnam |
| Research Site | Withdrawn | Ho Chi Minh City | 700000 | Vietnam |
| Research Site | Not yet recruiting | Ho Chi Minh City | 700000 | Vietnam |
| Research Site | Recruiting | Ho Chi Minh City | 70000 | Vietnam |
| Research Site | Not yet recruiting | Ho Chi Minh City | 70000 | Vietnam |
| Research Site | Recruiting | Vinh | 460000 | Vietnam |
| ID | Term |
|---|---|
| D001661 | Biliary Tract Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| C000613593 | durvalumab |
| C000614160 | trastuzumab deruxtecan |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
Not provided
Not provided