Perioperative Therapy for Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title: Perioperative Multidisciplinary Therapy for Technically Resectable Hepatocellular Carcinoma With Vein Thrombosis: An Exploratory Clinical Trail

Status Terminated

Clinical Trial Summary

This study aims to observe and evaluate the efficacy and safety of the perioperative multidisciplinary therapy that combines the preoperative transarterial chemoembolization(TACE) and the anti-programmed-death-1 antibody (anti-PD-1) Sintilimab Injection with or without radiotherapy of vein tumor thrombus followed by postoperative anti-PD-1 injection in the treatment of technically resectable hepatocellular carcinoma patients with vein thrombosis.

Clinical Trial Description

Hepatocellular carcinoma (HCC) has an insidious onset, high degree of invasion, and rapid disease progression. Tumor cells can easily invade the intrahepatic vasculature, especially the portal vein or hepatic venous system, and form portal vein tumor thrombus (PVTT) or hepatic vein tumor thrombus (HVTT).PVTT/HVTT is one of the main adverse factors for the long-term survival of HCC. The location and scope of its occurrence are closely related to the prognosis, and it is also a main hindrance to the improvement of the overall curative effect of HCC in recent years.

As the treatment of HCC converts to multi-disciplinary therapy, the neoadjuvant therapy will be commonly used in the treatment of HCC with PVTT.Early clinical data already support a safe combination of immune checkpoint inhibition with TACE. Moreover，The preliminary results of our previous trial (CISLD-5) showed that TACE combined with anti-programmed-death-1 antibody in patients with BCLC stage A/B HCC beyond Milan criteria has a significant effect.In addition, radiation therapy (RT) can irradiate both the tumor thrombus and the primary tumor .In numbers of retrospective studies, preoperative radiotherapy can achieve radical resection in some patients.

This study is to analyze the safety and efficacy of preoperative TACE and anti-PD-1 Injection combined with or without preoperative radiotherapy of vein tumor thrombus and postoperative anti-PD-1 injection in the treatment of technically resectable hepatocellular carcinoma patients with vein thrombosis. ;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

• NCT number: NCT04653389
• Study type: Interventional
• Source: Zhejiang University
• Status: Terminated
• Phase: Phase 2
• Start date: December 26, 2020
• Completion date: December 1, 2021