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This study is designed to combine anti-angiogenic drugs on the basis of PD-L1+ gemcitabine/cisplatin, hoping to further improve the curative effect of advanced BTC treatment and provide more choices for first-line treatment of BTC in China.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| adebrelimab combined with apatinib and gemcitabine and cisplatin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adebrelimab | Drug | adepelizumab ,1200mg, q3w |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | Progression-free Survival (PFS) is defined as the time from randomization to the first documented radiographic disease progression or death due to any cause, whichever occurs first, assessed by the Investigator per RECIST Version 1.1. | From first dose of study intervention until disease progression or death (whichever occurs first), up to approximately 6 months after the last subject enrolled |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival(OS) | Overall Survival(OS) is defined as the time from the date of the first dose of study intervention until death due to any cause. The measures of interest are median Overall Survival(OS) and Overall Survival at 12 months(OS12). | From first dose of study intervention until death, at least 12 months after the last subject enrolled |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Liu, MD | Contact | +86 137 8360 4602 | yaya7207@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Ying Liu, MD | Study Principal Investigator Henan Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HeNan | Recruiting | Zhengzhou | China |
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| Apatinib | Drug | apatinib,250mg,QD |
|
| gemcitabine and cisplatin | Drug | cisplatin 25mg/m2,gemcitabine 1000mg/m2 d1,d8,q3w |
|
| Objective Response Rate (ORR) | Objective Response Rate (ORR) is defined as the proportion of participants who achieved a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), assessed by BICR per RECIST Version 1.1. | From first dose of study intervention until disease progression or death (whichever occurs first), up to approximately 3 months after the last subject enrolled |
| Duration of Response(DOR) | Duration of Response(DOR) is defined as the time from the date of first documented response until the date of documented progression per RECIST 1.1 as assessed by the investigator or death due to any cause. | From first dose of study intervention until disease progression or death (whichever occurs first), up to approximately 6 months after the last subject enrolled |
| Incidence of treatment-emergent adverse events(AEs) | Incidence of treatment-emergent adverse events(AEs), including possible related adverse events(PRAEs), adverse event of special interests(AESIs), immune-mediated adverse events(imAEs), and serious adverse events(SAEs). | From first dose of study intervention until 90 days after last dose or death (whichever occurs first) |
| ID | Term |
|---|---|
| C553458 | apatinib |
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| 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 |
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