Phase 2 Study of Hepatic Arterial Infusion Chemotherapy Combined With Durvalumab and Lenvatinib for Treating Locally Advanced or Metastatic Intrahepatic Cholangiocarcinoma

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.

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)