NCT06859684

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Durvalumab	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
DRUG	hepatic arterial infusion chemotherapy (HAIC)	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).
DRUG	Lenvatinib	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)

Timeline

• Start date: 2025-03-01
• Primary completion: 2026-09-06
• Completion: 2027-03-06
• First posted: 2025-03-05
• Last updated: 2026-03-09

Locations

1 site across 1 country: China