Phase II Study of D-TACE-HAIC GEMOX Combined with Envafolimab and Lenvatinib for Treating Unresectable Intrahepatic Cholangiocarcinoma

What this Trial Is About

Researchers are evaluating a combination treatment involving D-TACE-HAIC using the GEMOX regimen, Envafolimab, and Lenvatinib for people with unresectable intrahepatic cholangiocarcinoma. This prospective, single-arm, multicenter, phase II trial aims to assess how well this combined therapy works and its safety for patients who cannot undergo surgery. The study is led by Fujian Provincial Hospital and focuses on this specific liver cancer type with complex treatment needs. Participants will receive the combination therapy of D-TACE-HAIC alongside Envafolimab and Lenvatinib. The treatment plan involves administering these therapies together to target the cancer, with all patients placed in a single combination therapy group. The study will observe the effects of this combined approach over time, monitoring its impact on the disease. During the study, participants will be evaluated through imaging scans to measure tumor response four weeks after starting treatment. Researchers will also track overall survival and progression-free survival for up to 60 months and monitor any treatment-related side effects for up to 12 months. Other assessments include disease control rate and safety evaluations. The total participation period extends from enrollment through long-term follow-up to understand the treatments outcomes and safety profile.

D-TACE-HAIC Combined With Envafolimab and Lenvatinib for Unresectable ICC