A Phase 1/2 interventional study of HAIC Combined Regimen Treatment Group in Biliary Tract Cancer, sponsored by West China Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-13.
Sponsored by West China Hospital · Phase 1/2, Interventional, and Treatment
Advanced biliary tract cancer has a poor prognosis and limited efficacy with current regimens. This multicenter single-arm phase Ib/II trial explores the efficacy and safety of HAI-GP chemotherapy combined with intraoperative arterial envafolimab and lenvatinib as first-line therapy for unresectable BTC. It conducts dose exploration to confirm the optimal dosage and evaluates clinical outcomes, aiming to establish a better comprehensive treatment strategy.
484 studies on the registry are indexed under Biliary Tract Neoplasms; 187 are open to participants now.
This study's planned enrollment of 20 is below the median of 56 across 404 interventional studies indexed under Biliary Tract Neoplasms.
Browse Biliary Tract Neoplasms studies →West China Hospital is the lead sponsor of 483 studies on the registry; 240 are open to participants now.
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Patients must meet all of the following inclusion criteria:
Adequate organ function to meet the criteria for chemotherapy:
Exclusion Criteria:
Patients meeting any of the following criteria will be excluded:
Meeting any of the following cardiovascular criteria:
In Phase Ib, nine patients will be enrolled and allocated to three dose cohorts to receive the combination regimen of HAIC (GP) + intra-arterial infusion of envafolimab + lenvatinib. Dose-limiting toxicities (DLTs) will be monitored for 28 days following administration. If no DLTs occur, the regimen will be considered tolerable, and patients will continue follow-up until 60 days post-administration. Investigators confirm Phase II initiation and optimal dose per safety data. In Phase II, 20 subjects adopt the optimized dose regimen. They firstly receive two cycles of combined treatment for efficacy evaluation. Those with clinical benefits finish six cycles in total, then switch to maintenance treatment until treatment ends, disease progresses, adverse reactions are intolerable, subjects withdraw consent or treatment is terminated by researchers. Robotic arm is applied to assist accurate hepatic artery catheterization and stable drug infusion during interventional procedures.
Drug: HAIC Combined Regimen Treatment Group
In Phase Ib, nine patients will be enrolled and allocated to three dose cohorts to receive the combination regimen of HAIC (GP) + intra-arterial infusion of envafolimab + lenvatinib. Dose-limiting toxicities (DLTs) will be monitored for 28 days following administration. If no DLTs occur, the regimen will be considered tolerable, and patients will continue follow-up until 60 days post-administration. Investigators confirm Phase II initiation and optimal dose per safety data. In Phase II, 20 subjects adopt the optimized dose regimen. They firstly receive two cycles of combined treatment for efficacy evaluation. Those with clinical benefits finish six cycles in total, then switch to maintenance treatment until treatment ends, disease progresses, adverse reactions are intolerable, subjects withdraw consent or treatment is terminated by researchers. Robotic arm is applied to assist accurate hepatic artery catheterization and stable drug infusion during interventional procedures.
Primary endpoint for Phase Ib: Dose-Limiting Toxicity (DLT)
The DLT observation period extends from the first dose to 28 days post-administration. If, among 9 patients enrolled in Phase Ib, the number experiencing DLT is ≤1 ，the dose level will be considered well tolerated; if the number is ≥2, dose reduction and re-evaluation will be required until a well-tolerated dose is established as the Recommended Phase II Dose (RP2D).
Time frame: Within 28 days after first dose (one safety observation cycle)
Primary endpoint for Phase II:Objective Response Rate (ORR)
Primary endpoint for Phase II:Objective Response Rate (ORR), defined as the proportion of patients achieving a predefined reduction in tumor volume maintained for the minimum required duration, including Complete Response (CR) and Partial Response (PR).
Time frame: Every 6 weeks (every two 21-day treatment cycles), up to completion of maximum six 21-day combination treatment cycles
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