Liver-directed chemotherapy plus systemic drugs to downstage biliary tract cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional protocol combines hepatic arterial infusion chemotherapy (HAIC) — using regimens such as GOLF or FOLFOX — with systemic agents including gemcitabine, bevacizumab, and PD‑1/PD‑L1 inhibitors to try to downstage biliary tract cancers. The goal is to increase objective tumor responses and convert unresectable or borderline tumors into candidates for curative resection. Eligible patients are treatment‑naive adults with intrahepatic or perihilar cholangiocarcinoma or gallbladder cancer, limited or no distant metastasis, ECOG <2, and preserved liver and organ function. Treatment is delivered at Peking University Cancer Hospital and involves repeated locoregional infusions and systemic therapy with monitoring for response and safety.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age: 18-80 years, both genders.
* Diagnosis of biliary tract cancer (including intrahepatic cholangiocarcinoma, perihilar cholangiocarcinoma, and gallbladder cancer) and confirmed by histopathological or cytopathological examination.
* Without distant metastasis or limited distant metastasis
* Treatment-naive.
* ECOG PS score \< 2.
* Child-Pugh score: Class A or B (≤7).
* Normal major organ function, meeting the following standards:(1) Blood routine examination:A. Hb≥90 g/L;B. ANC≥1.5×10\^9/L;C. PLT≥75×10\^9/L;(2) Biochemical examination:A. ALB ≥30g/L;B. ALT and AST\<5×ULN;C. TBiL ≤5×ULN;D. Creatinine ≤1.5×ULN;(3) Coagulation function:A. International normalized ratio (INR) ≤1.5×ULN;B. Activated partial thromboplastin time (APTT) ≤1.5×ULN.

Exclusion Criteria:

* Coexistent or synchronous malignancies.
* Distal cholangiocarcinoma.
* Allergic to contrast agents or oxaliplatin.
* Pregnant or lactating women.
* Multiple extrahepatic metastases or combined malignant pleural and peritoneal effusions.
* History of organ transplantation.
* With infections requiring anti-infection treatment.
* Severe and irreparable coagulation dysfunction.

Where it's running

• Peking University Cancer Hospital
  Beijing, China Recruiting
• Peking University Cancer Hospital
  Beijing, China Not yet recruiting

Study contacts

• Study coordinator: Xiaodong Wang
• Email: xiaodongw75@yahoo.com
• Phone: 0086-18611586227

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.