drugset / Trial / NCT06896396

Icaritin Soft Capsules+TACE+Immunotherapy+Targeted Therapy Versus TACE+Immunotherapy+Targeted Therapy for Unresectable Hepatocellular Carcinoma

NCT06896396

Phase 1/2 Not yet recruiting 60 enrolled Zhiyong Huang
RandomizedParallel-groupOpen-labelTreatment

Summary

Hepatocellular carcinoma (HCC) is one of the most common malignant tumors and the leading cause of cancer-related death worldwide. Surgical resection has always been the best hope for long-term survival of patients with HCC. However, only a few patients have the opportunity to undergo surgery, and more than 70% of HCC patients have lost the opportunity of surgery at the time of diagnosis. The treatment measures for these patients are mainly transcatheter arterial chemoembolization and systemic therapy. In recent years, systemic therapies represented by targeted therapy and immunotherapy have made important progress in the field of liver cancer, improving the survival of patients with advanced unresectable HCC. Icaritin soft capsule is a monomer compound extracted, isolated, purified and enzymatically hydrolyzed from the natural medicinal plant Epimedium. It was approved for marketing on January 10, 2022 for patients with advanced first-line HCC. Icaritin soft capsules have the potential to delay TKI resistance and enhance the efficacy of PD-1 inhibitors. The aim of this study is to explore whetherIcaritin soft capsules and TACE combined with Immunotherapy and Targeted Therapy can improve the therapeutic effect of advanced HCC, ultimately prolong the survival time of patients, and provide a new treatment direction for patients with advanced HCC.

Timeline

Start
2025-04-01
Primary completion
2027-06-01
Completion
2028-02-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Icaritin Small molecule 6 unknown Oral
Background Lenvatinib Small molecule 8 mg
Background Lenvatinib Small molecule 12 mg
Background Pembrolizumab Monoclonal antibody