GemCis Plus PD-1/PD-L1 Inhibitor in Advanced Biliary Tract Cancer: Efficacy and Immune Microenvironment （BTC-IM-1）
A Prospective, Non-interventional Study of Gemcitabine/Cisplatin Combined With PD-1/PD-L1 Inhibitor as First-line Treatment in Treatment-naïve Advanced Biliary Tract Cancer Patients: Efficacy and Immune Microenvironment Dynamics
Fudan University
100 participants
May 23, 2025
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria12
- 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 Criteria7
- 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.
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Interventions
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.
Locations(1)
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NCT06988592