Hepatocellular Carcinoma Clinical Trial
Official title:
TACE/HAIC Combined With Lenvatinib and Sintilimab in Neoadjuvant Therapy for Patients With Potentially High Recurrence Risk After Liver Cancer Resection: a Prospective, Randomized, Controlled Clinical Study
The purpose of the study is to observe the effect of TACE/HAIC combined with lenvatinib and sintilimab as a neoadjuvant therapy before liver resection in preventing the recurrence in high-risk patients with hepatocellular carcinoma.
For patients with hepatocellular carcinoma staged BCLC B/C(intermediate hepatocellular carcinoma)，TACE is a widely used treatments .However ,The efficacy of TACE in intermediate hepatocellular carcinoma is not very satisfactory.A series of study demonstrated that direct hepatectomy has better prognosis compared with TACE for these intermediate hepatocellular carcinoma patients.Despite of this ,The high recurrence risk, high probability of surgical complications, and poor treatment effect after recurrence of intermediate hepatocellular carcinoma after direct surgical treatment is a still a tough problem to be solved.Recently, investigators have showed that hepatic arterial infusion of FOLFOX-based chemotherapy (HAIC) was safe and efficient for advanced HCC patients. The combination of TACE with HAIC (TACE-HAIC) was proved to increase the local doses of chemotherapeutic agents in the liver .In addition, Lenvatinib was proved non-inferior to sorafenib in overall survival in advanced hepatocellular carcinoma, and Programmed Cell Death Protein-1 (PD-1) antibody was effective and tolerable in patients with advanced hepatocellular carcinoma.In this context，for those patients with potentially high recurrence risk after liver resection, the investigators carried out this prospective randomized control to demonstrate the superiority of TACE/HAIC combined with PD-1 antibody and lenvatinib as a neoadjuvant therapy before liver resection over direct hepatectomy. ;
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