A Study to Evaluate TACE Sequential Tislelizumab as Adjuvant Therapy in Participants With HCC at High Risk of Recurrence After Curative Resection

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open label, multi-center, phaseⅡstudy to evaluate the efficacy and safety of TACE sequential tislelizumab as adjuvant therapy in hepatocellular carcinoma (HCC) patients who are at high risk of recurrence after curative resection.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhejiang University
• Collaborators: First Hospital of China Medical University; Hainan People's Hospital; Shandong Cancer Hospital and Institute; The Affiliated Hospital Of Southwest Medical University; Tianjin Third Central Hospital

Criteria

Inclusion Criteria:

• Subjects with a histopathological or cytologically diagnosis of HCC

• Subjects who have undergone a curative resection

• High risk for HCC recurrence as protocol defined

• No previous systematic treatment and locoregional therapy for HCC

• Child-Pugh Score, Class A

• ECOG performance status 0 or 1

• Full recovery from surgical resection

• Adequate organ function

• Absence of major macrovascular invasion

• No extrahepatic spread

• Life expectancy of at least 6 months

Exclusion Criteria:

• Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC

• Evidence of residual, recurrent, or metastatic disease

• Known history of serious allergy to any monoclonal antibody

• History of hepatic encephalopathy

• Tumor thrombus in portal vein or superior mesenteric vein or inferior caval vein

• Portal hypertension with bleeding esophageal or gastric varices within 6 months prior to initiation of treatment

• Any bleeding or thrombotic disorder within 6 months prior to initiation of treatment

• Any active malignancy within 2 years prior to the start of treatment

• Active or history of autoimmune disease

• Other acute or chronic conditions, psychiatric disorders, or laboratory abnormalities that may increase the risk of study participation

• Prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or other immunotherapy

• Pregnant or lactating women