Actively Recruiting
Hepatic Arterial Infusion Chemotherapy Combined With Durvalumab and Lenvatinib in Patients With Locally Advanced or Metastatic Intrahepatic Cholangiocarcinoma: a Phase 2 Study (HAIC-quad Trial)
Led by West China Hospital · Updated on 2026-03-09
25
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new treatment approach for patients with advanced unresectable or metastatic intrahepatic cholangiocarcinoma (ICC), a type of liver cancer. The study is a Phase 2 clinical trial investigating whether combining hepatic arterial infusion chemotherapy (HAIC) with the drugs durvalumab and lenvatinib can provide better treatment outcomes compared to current systemic therapies, which have limited effectiveness. The treatment involves HAIC using a GemCis chemotherapy regimen delivered directly into the liver artery every three weeks for 4 to 6 cycles, combined with durvalumab given intravenously either every three weeks during combination therapy or every four weeks for maintenance. Lenvatinib is taken orally daily, with the dose adjusted by weight, starting on day three of each three-week cycle. The study is designed to explore this combination as a first-line therapy to improve local drug concentration while reducing side effects. Participants will be monitored for their tumor response using RECIST 1.1 criteria, with the primary outcome being the objective response rate over about 26 months. Secondary outcomes include overall survival, progression-free survival, and recording any adverse events up to 36 months. The study requires participants to have good performance status and at least one measurable tumor lesion. The total participation timeline includes treatment cycles and extended follow-up to assess safety and effectiveness outcomes.
CONDITIONS
Brief Title
Hepatic Arterial Infusion Chemotherapy (HAIC) Combined With Durvalumab and Lenvatinib in Patients With Locally Advanced or Metastatic Intrahepatic Cholangiocarcinoma: a Phase 2 Study(HAIC-quad Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed intrahepatic cholangiocarcinoma with unresectable or metastatic disease and no prior systemic treatment
- Disease recurrence more than 6 months after radical surgery or completion of adjuvant therapy
- WHO/ECOG performance status of 0 or 1
- At least one target lesion measurable by RECIST 1.1 criteria
You will not qualify if you...
- Previous systemic treatment for intrahepatic cholangiocarcinoma
- Severe liver dysfunction (Child-Pugh C), significant jaundice, hepatic encephalopathy, refractory ascites, or hepatorenal syndrome
- Severe and uncorrectable blood clotting problems
- Active hepatitis or severe infection that cannot be treated
- Cachexia or failure of multiple organs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 12 to 18 weeks (4 to 6 cycles of 3 weeks each)
Participants receive hepatic arterial infusion chemotherapy combined with Durvalumab and Lenvatinib. Chemotherapy cycles are repeated every 3 weeks for 4 to 6 cycles as determined by the investigator.
Visits every 3 weeks for chemotherapy administration and drug dosing
Duration - Up to approximately 36 months
After treatment completion, participants are monitored for overall survival, progression-free survival, and adverse events.
Periodic visits as scheduled for assessments
Trial Site Locations
Total: 1 location
1
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Actively Recruiting
Research Team
Y
Yun X Zhang, PHD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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