GemCis Plus PD-1/PD-L1 Inhibitor in Advanced Biliary Tract Cancer: Efficacy and Immune Microenvironment （BTC-IM-1）

NCT ID: NCT06988592

Last Updated: 2025-05-29

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-23
• Study Completion Date: 2027-12-30

Brief Summary

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.

Detailed Description

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.

Conditions

Advanced Biliary Tract Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

BTC cohort

GemCis plus PD-1/PD-L1 inhibitor

Intervention Type: 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.

Interventions

GemCis plus PD-1/PD-L1 inhibitor

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.

Intervention Type: DRUG

Eligibility Criteria

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:

• ANC ≥1.5 × 10⁹/L, platelets ≥100 × 10⁹/L, hemoglobin ≥9 g/dL.
• Total bilirubin ≤1.5 × ULN, AST/ALT ≤3 × ULN (≤5 × ULN if liver metastases).
• Creatinine ≤1.5 × ULN or CrCl ≥60 mL/min.
• Willing to provide archival/fresh tumor tissue and peripheral blood samples.
• Signed informed consent.

Exclusion Criteria

• Prior systemic therapy.
• Active autoimmune disease requiring immunosuppression.
• Active infection requiring IV antibiotics.
• HIV-positive or active HBV/HCV infection (HBsAg+ with HBV DNA ≥2000 IU/mL; HCV RNA+).
• Symptomatic CNS metastases.
• Pregnancy/lactation.
• Any condition compromising protocol compliance or data interpretation per investigator.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Peng Wang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Peng Wang, MD

Role: CONTACT

peng_wang@fudan.edu.cn

86-21-64041990

Facility Contacts

Peng Wang

Role: primary

peng_wang@fudan.edu.cn

+86021-64041990

Other Identifiers

BTC-IM-1

Identifier Type: -

Identifier Source: org_study_id