Transarterial Chemoembolization Plus Camrelizumab and Apatinib for Unresectable Hepatocellular Carcinoma : a Randomised , Open Label, Multicenter Controlled Trial
Hepatocellular carcinoma (HCC) is the sixth most common cancer and the third most common cause of cancer-related death worldwide. The majority of patients with HCC are diagnosed as intermediate or advanced stage disease, and not eligible for curative treatments including transplantation, resection, and ablation. Transarterial chemoembolization (TACE) is recommended as first-line treatment for patients with intermediate-stage HCC, while it is also widely used in the unresectable HCC. The clinical efficacy and safety in advanced HCC patients of camrelizumab plus apatinib were reported in phase 3 trial (CARES-310). Camrelizumab plus apatinib with a median progression-free survival of 5.7 months and a median overall survival of 22.1 months in advanced HCC. This study is randomized, open-label, multicenter controlled trial; which was focused in initial BCLC-B/C HCC patients. This study aimed to compare the efficacy and safety of TACE plus programmed death-1 inhibitor (camrelizumab), and anti-angiogenic therapy (apatinib) with camrelizumab plus apatinib.
• Histopathologically or clinically confirmed hepatocellular carcinoma
• 18-80 years old.
• Performance status (PS) ≤ 1 (ECOG scale).
• Barcelona clinical liver cancer (BCLC) stage B or stage C.
• Initial treatment of hepatocellular carcinoma.
• According to mRECIST, there is at least one measurable lesion.
• Child Pugh score ≤ 7.
• Participant has sufficient organ and marrow functions.
• Expected survival time ≥ 12 weeks.
⁃ For women of childbearing age or male patients whose sexual partners are women of childbearing age, effective contraceptive measures should be taken during the whole treatment period and 6 months after the last medication.
⁃ Sign the written informed consent, and be able to follow the visit and relevant procedures specified in the plan.