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Hepatic Arterial Infusion Chemotherapy Plus Envafolimab and Lenvatinib for First-Line Unresectable Advanced Biliary Tract Cancer

NCT07636798 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-07-13

No results posted yet for this study

Summary

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • West China Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2029-03-31
Completion
2029-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07636798 on ClinicalTrials.gov