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.
Absolute neutrophil count ≥ 1.0 × 109/L;
Platelet count ≥ 75 × 109/L;
Hemoglobin concentration ≥ 90g/L;
Serum albumin concentration ≥ 28g/L;
1) Diffuse infiltrative lesions of the liver and brain metastases; 2) There are TACE contraindications, such as portosystemic shunt, hepatic blood flow and obvious atherosclerosis; 3) Individuals allergic to intravenous contrast agents; 4) Local treatment has been performed on existing lesions (e.g.: TACE、 Melting, particles TARE、 Hepatic artery infusion chemotherapy or radiotherapy); 5) The subject is unable to undergo enhanced liver CT or MRI scans; 6) Previous history of liver transplantation or current candidate for liver transplantation; 7) Pregnant, lactating women or participants planning to undergo contraceptive procedures within 2 years; 8) Patients with combined HIV and syphilis infections; 9) Patients with other concurrent malignant tumors or other malignant tumors within the first 5 years of enrollment; 10) Patients with severe functional impairments of the heart, kidneys, and other organs; 11) Severe clinical active infection>Level 2 (NCI-CTC version 5.0); 12) Mental illness patients who may affect the informed consent process; The patient is unable to take oral medication; The patient participated in clinical trials of other drugs within 12 months prior to enrollment.
Zhiyong Huang
Lead sponsor
Tongji Hospital
Sponsor institution