drugset / Trial / NCT07304388

HAIC Plus Systemic Chemotherapy, Lenvatinib and Toripalimab in Advanced ICC

NCT07304388

Phase 2 Completed 96 enrolled Sun Yat-sen University
RandomizedParallel-groupOpen-labelTreatment

Summary

Prognosis for unresectable intrahepatic cholangiocarcinoma (ICC) remains poor. Treatment combination known as Gemox (systemic chemotherapy of gemcitabine and oxaliplatin), along with lenvatinib and toripalimab, has shown favor results for ICC patients. However, Hepatic Arterial Infusion Chemotherapy (HAIC), which delivers chemotherapy directly to the liver, has also demonstrated benefits in controlling the cancer locally and improving survival for patients with ICC. Based on these promising approaches, this study aims to find out if adding HAIC to the systemic chemotherapy-based treatment can help extending patients survival.

Timeline

Start
2023-02-10
Primary completion
2025-04-01
Completion
2025-06-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Gemcitabine Small molecule 1 g Intravenous
Comparator Lenvatinib Small molecule 8 mg Oral
Comparator Lenvatinib Small molecule 12 mg Oral
Comparator Oxaliplatin Small molecule 85 mg/m2 Other
Comparator Toripalimab Monoclonal antibody 240 mg Intravenous