Actively Recruiting
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)
Led by West China Hospital · Updated on 2026-03-09
25
Participants Needed
1
Research Sites
105 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
At present, the first-line treatment for patients with advanced unresectable intrahepatic cholangiocarcinoma is mainly systemic treatment, but the improvement in efficacy is limited and is not enough to meet the current clinical treatment needs. Hepatic artery infusion chemotherapy (HAIC) has the advantages of increasing local drug concentration and reducing toxic side effects compared to systemic intravenous chemotherapy. In order to enable patients with advanced intrahepatic cholangiocarcinoma to obtain better treatment effects, this study plans to explore HAIC combined with durvalumab and lenvatinib as the first-line treatment for patients with locally advanced or metastatic ICC, in order to provide a better treatment choice for their comprehensive treatment.
CONDITIONS
Official 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
- Patients with tumor invasion preventing surgery, decompensated cirrhosis or severe portal hypertension with unsafe liver remnant
- Patients with multiple tumors in both liver lobes or distant lymph node or organ metastasis
- 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 cancer
- 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
Trial Site Locations
Total: 1 location
1
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Actively Recruiting
Research Team
Y
Yun X Zhang, PHD
CONTACT
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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