Status:
RECRUITING
GemCis Plus PD-1/PD-L1 Inhibitor in Advanced Biliary Tract Cancer: Efficacy and Immune Microenvironment （BTC-IM-1）
Lead Sponsor:
Fudan University
Conditions:
Advanced Biliary Tract Cancer
Eligibility:
All Genders
18+ years
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) c...
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 fir...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 23 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06988592
Start Date
May 23 2025
End Date
December 30 2027
Last Update
May 29 2025
Active Locations (1)
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1
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200032