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

Launched by FUDAN UNIVERSITY · May 16, 2025

Keywords

ClinConnect Summary

This clinical trial, called BTC-IM-1, is looking at how well a combination of standard chemotherapy (gemcitabine and cisplatin, or GemCis) and a type of immunotherapy (PD-1/PD-L1 inhibitors) works for patients with advanced biliary tract cancer, which includes cancers of the bile ducts and gallbladder. The goal is to understand not only how effective this treatment is but also how it affects the immune system in patients who are just starting treatment and have not received any other cancer therapy before.

To participate in this trial, you need to be at least 18 years old and have a confirmed diagnosis of unresectable or metastatic cholangiocarcinoma, meaning the cancer cannot be removed through surgery. You also should not have had any previous cancer treatments. Participants will receive the combination therapy as their first-line treatment and will need to provide some blood and tissue samples for research purposes. The trial is not yet recruiting patients, and those who join can expect close monitoring of their health and response to treatment throughout the study.

Gender

ALL

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.