NCT04653389

Perioperative Therapy for Hepatocellular Carcinoma

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Sintilimab Injection	Sintilimab Injection is used as neoadjuvant therapy and adjuvant therapy.
DRUG	TACE	The first TACE and Sintilimab Injection will be initiated simultaneously.
RADIATION	Radiotherapy	Use Cone Beam computor tomography(CBCT) locates the lession before the therapy.

Timeline

• Start date: 2020-12-26
• Primary completion: 2021-10-01
• Completion: 2021-12-01
• First posted: 2020-12-04
• Last updated: 2022-01-11

Locations

1 site across 1 country: China