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

NCT ID: NCT04981665

Last Updated: 2022-01-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-08
• Study Completion Date: 2024-12-31

Brief 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.

Detailed Description

Hepatocellular carcinoma (HCC) is a malignant tumor with high morbidity and mortality. Surgical resection is the most important radical treatment. However, the recurrence rate is high especially in the patients with high risk of recurrence after curative resection. How to reduce postoperative recurrence and improve survival is currently a direction that is worth exploring.

Until now there is no standard postoperative adjuvant therapy. Previous studies have shown that TACE combined with PD-1 inhibitors has a synergistic enhancement effect, and this study is to explore the efficacy and safety of TACE sequential tislelizumab as adjuvant therapy in HCC patients who are at high risk of recurrence after curative resection.

Conditions

Hepatocellular Carcinoma; Adjuvant Therapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Postoperative TACE + Tislelizumab 200mg IV Q3W

TACE will be performed after curative resection (4±1w) once and then Tislelizumab Injection will be initiated after TACE (5±2d). Tislelizumab will be administered every three weeks, until the disease recurrence, intolerable toxicity, death, withdrawal of consent or completion of 17 cycles of Tislelizumab.

Group Type: EXPERIMENTAL

Tislelizumab

Intervention Type: DRUG

Tislelizumab 200mg IV Q3W

TACE

Intervention Type: DRUG

TACE will be performed after curative resection (4±1w)

Interventions

Tislelizumab

Tislelizumab 200mg IV Q3W

Intervention Type: DRUG

TACE

TACE will be performed after curative resection (4±1w)

Intervention Type: DRUG

Other Intervention Names

BGB-A317; Immunotherapy; Anti-PD-1 therapy; Transarterial Chemoembolization

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Hospital of China Medical University

OTHER

Sponsor Role: collaborator

Shandong Cancer Hospital and Institute

OTHER

Sponsor Role: collaborator

The Affiliated Hospital Of Southwest Medical University

OTHER

Sponsor Role: collaborator

Hainan People's Hospital

OTHER

Sponsor Role: collaborator

Tianjin Third Central Hospital

OTHER

Sponsor Role: collaborator

Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

TingBo Liang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

the First Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Tingbo Liang

Role: CONTACT

liangtingbo@zju.edu.cn

+8613666676128

Tao Ma

Role: CONTACT

zjumatao@zju.edu.cn

+8613857148997

Other Identifiers

BGB-A317-2008

Identifier Type: -

Identifier Source: org_study_id