Actively Recruiting
GemCis Plus PD-1/PD-L1 Inhibitor in Advanced Biliary Tract Cancer: Efficacy and Immune Microenvironment （BTC-IM-1）
Led by Fudan University · Updated on 2025-05-29
100
Participants Needed
1
Research Sites
135 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
GemCis Plus PD-1/PD-L1 Inhibitor in Advanced Biliary Tract Cancer: Efficacy and Immune Microenvironment （BTC-IM-1）
Who Can Participate
Eligibility Criteria
You may qualify if you...
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Age ≥18 years.
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Histologically confirmed unresectable/metastatic cholangiocarcinoma (intrahepatic, extrahepatic, or gallbladder).
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No prior systemic anticancer therapy (chemotherapy, targeted therapy, or immunotherapy).
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Planned to receive GemCis+PD-1/PD-L1 inhibitor as standard first-line treatment.
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≥1 measurable lesion per RECIST 1.1.
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ECOG performance status 0-1.
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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.
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Willing to provide archival/fresh tumor tissue and peripheral blood samples.
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Signed informed consent.
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
P
Peng Wang, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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