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To evaluate the efficacy and immune microenvironment changes in treatment-naïve advanced biliary tract cancer (BTC) patients receiving first-line standard therapy with gemcitabine/cisplatin (GemCis) combined with PD-1/PD-L1 inhibitors.
This is a prospective, non-interventional, observational study evaluating the efficacy and immune microenvironment changes in treatment-naïve advanced biliary tract cancer (BTC) patients receiving first-line standard therapy with gemcitabine/cisplatin (GemCis) combined with PD-1/PD-L1 inhibitors. The primary endpoint is objective response rate (ORR), with secondary endpoints including disease control rate (DCR), duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS), and immune profiling of tumor tissue and peripheral blood before and after treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BTC cohort |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GemCis plus PD-1/PD-L1 inhibitor | Drug | Gemcitabine: 1000 mg/m², intravenous infusion, on Day 1 and Day 8 Cisplatin: 25 mg/m², intravenous infusion, on Day 1 and Day 8 PD-1/PD-L1 inhibitor: An approved agent (e.g., Pembrolizumab, Nivolumab, Atezolizumab, etc.) will be selected based on clinical practice and administered at standard doses and schedules. Each treatment cycle lasts 21 days, continuing until disease progression, unacceptable toxicity, or patient/physician decision to discontinue. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 | OS is defined as the time from study treatment to the date of death of the subject, regardless of the cause of death. | max 42 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 | ORR is defined as the percentage of participants who have a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters). Responses are according to RECIST 1.1 as assessed by investigator. |
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Inclusion Criteria:
Age ≥18 years.
Histologically confirmed unresectable/metastatic cholangiocarcinoma (intrahepatic, extrahepatic, or gallbladder).
No prior systemic anticancer therapy (chemotherapy, targeted therapy, or immunotherapy).
Planned to receive GemCis+PD-1/PD-L1 inhibitor as standard first-line treatment.
≥1 measurable lesion per RECIST 1.1.
ECOG performance status 0-1.
Adequate organ function:
Willing to provide archival/fresh tumor tissue and peripheral blood samples.
Signed informed consent.
Exclusion Criteria:
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This is a prospective, non-interventional, observational study evaluating the efficacy and immune microenvironment changes in treatment-naïve advanced biliary tract cancer (BTC) patients receiving first-line standard therapy with gemcitabine/cisplatin (GemCis) combined with PD-1/PD-L1 inhibitors.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peng Wang, MD | Contact | 86-21-64041990 | peng_wang@fudan.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital, Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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A baseline tumor biopsy and blood collection before initiation of treatment, followed by a second tumor biopsy with paired blood collection after the first response evaluation will be planned.
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| max 24 months |
| Disease control rate (DCR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 | DCR is defined as the proportion of patients with complete response (CR), partial response (PR) and stable disease (SD). | max 24 months |
| Duration of Response (DOR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 | DOR is defined as the time from first documented complete or partial response until disease progression, death from any cause, or censoring at date of last tumor assessment. | max 24 months |
| Time to Response (TTR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 | TTR is defined as the time from the start of treatment until the first objective observation of a response (either partial response, PR, or complete response, CR), provided that the response is subsequently confirmed | max 24 months |
| Progression Free Survival (PFS) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 | PFS is defined as the time from study treatment to disease progression or all-cause death as assessed by the investigator (whichever occurs first) | max 24 months |
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experience at least one AE will be reported. | max 42 months |
| Translational study | Proportion of different immune cell types in tumors and blood based on RNA sequencing between two groups. | max 24 months |