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)

NCT06859684 | Recruiting Phase 2 DMC

• 1 other identifier: HAIC-quad-01
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Intrahepatic Cholangiocarcinoma (Icc); HAIC; Durvalumab

Keywords

locally advanced or metastatic intrahepatic cholangiocarcinoma; durvalumab; Lenvatinib; HAIC

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Disease assessments based on investigator assessments were determined by using RECIST version 1.1 guidelines. The ORR was defined as the percentage of patients with confirmed complete response (CR) or confirmed partial response (PR). The CR was defined as disappearance of all target and non-target lesions and no new lesions. The PR was defined as \>= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new non-target lesion. A confirmed CR or PR was defined as 2 CRs or 2 PRs with no evidence of progression in-between. Patients who discontinued randomized treatment without progression, received a subsequent anti-cancer therapy and then responded were not included as responders for ORR.

  Up to approximately 26 months

Secondary Outcomes (3)

• Overall Survival (OS)

  Up to approximately 36 months

• Progression-free Survival (PFS)

  Up to approximately 26 months

• Number of Participants Who Experience One or More Adverse Events (AE)

  Up to approximately 36 months

Study Arms (1)

HAIC-quad Arm

EXPERIMENTAL

Drug: Durvalumab; Drug: hepatic arterial infusion chemotherapy (HAIC); Drug: Lenvatinib

Interventions

Durvalumab DRUG

Durvalumab: During combination therapy: 1500 mg, Q3W, during combination therapy, on days 3-5 of each 3-week cycle (determined by the investigator); during maintenance therapy: 1500 mg Q4W

HAIC-quad Arm

Lenvatinib DRUG

Lenvatinib 8mg (weight \<60 kg) or 12mg (weight ≥60 kg) oral QD, during combination therapy, starting on day 3 of each 3-week cycle (determined by the investigator)

HAIC-quad Arm

hepatic arterial infusion chemotherapy (HAIC) DRUG

hepatic arterial infusion chemotherapy (HAIC) : GemCis regimen was adopted, with the specific regimen as follows: cisplatin 60 mg/m2 on the first day, arterial infusion for half an hour, gemcitabine 1000 mg/m2 on the first day, arterial infusion for half an hour, repeated once every 3 weeks, and 4-6 cycles of treatment (the specific number of cycles was determined by the investigator according to the patient's condition).

HAIC-quad Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed intrahepatic cholangiocarcinoma, with a preliminary diagnosis of unresectable or metastatic disease and no previous systemic treatment.
• Anatomical factors: ① Patients with invasion of the portal vein, hepatic vein or main bile duct, who cannot undergo resection and reconstruction; ② Patients with decompensated cirrhosis or severe portal hypertension, and the residual liver FLR does not meet the safe liver resection decision-making system Biological factors: ① Multiple tumors in the left and right livers; ② Metastasis to distant lymph nodes such as the para-aorta or distant organ metastasis
• WHO/ECOG PS of 0 or 1
• There was at least 1 target lesion (TL) that met the RECIST 1.1 criteria

You may not qualify if:

• Patients who have received systemic treatment in the past.
• Patients with severe liver dysfunction (Child-Pugh C grade), or significant jaundice, hepatic encephalopathy, refractory ascites, or hepatorenal syndrome.
• Patients with severe and uncorrectable coagulation dysfunction.
• Patients with active hepatitis or severe infection who cannot be treated simultaneously.
• Patients with cachexia or multiple organ failure.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, China

RECRUITING

MeSH Terms

Conditions

Cholangiocarcinoma; Cirrhosis, Familial, with Pulmonary Hypertension

Interventions

durvalumab; lenvatinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Yun X Zhang, PHD

CONTACT

18011410585; zhangxiaoyun@wchscu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Liver Surgery Department, West China Hospital, Sichuan University

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 5, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): September 6, 2026
• Study Completion (Estimated): March 6, 2027
• Last Updated: March 9, 2026

Record last verified: 2026-03

Locations

CN (1)