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

Official Title ICMJE A Phase 2, Open-Label, Multi-Center, Single Arm Study to Evaluate the Efficacy and Safety of TACE Sequential Tislelizumab as Adjuvant Therapy in Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection

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.

Study Overview

• Status: Recruiting
• Conditions: Hepatocellular Carcinoma; Adjuvant Therapy
• Intervention / Treatment: Drug: Tislelizumab; Drug: TACE

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Tingbo Liang; Phone Number: +8613666676128; Email: liangtingbo@zju.edu.cn
• Study Contact Backup: Name: Tao Ma; Phone Number: +8613857148997; Email: zjumatao@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • Recruiting
      • the First Affiliated Hospital, School of Medicine, Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Tislelizumab; Tislelizumab 200mg IV Q3W; Other Names: BGB-A317; Immunotherapy; Anti-PD-1 therapy; Drug: TACE; TACE will be performed after curative resection (4±1w); Other Names: Transarterial Chemoembolization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
2-year Recurrence Free Survival Rate (2-year RFS rate)	2-year RFS rate is defined as the proportion of patients alive and free of recurrence at 2 years after curative resection.	Observation period 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events (AEs)	The grade of AEs and the number of patients with AEs are assessed based on CTCAE v5.0	24 months
Recurrence-Free Survival (RFS)	RFS is defined as the time from the date of curative resection to the first documented recurrence or death due to any cause, whichever occurs first.	24 months
Time to recurrence (TTR)	TTR is defined as the time from the date of curative resection to the first documented recurrence.	24 months
Overall Survival (OS）	OS is defined as the time from the date of curative resection until death due to any cause.	24 months
1-year RFS rate	1-year RFS rate is defined as the proportion of patients alive and free of recurrence at 1 years after curative resection.	12 months
1-year OS rate/2-year OS rate	OS rate is defined as the proportion of patients who have not experienced death from any cause at 12 and 24 months after curative resection.	12 months/24 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2021
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: July 25, 2021
• First Submitted That Met QC Criteria: July 25, 2021
• First Posted (Actual): July 29, 2021

Study Record Updates

• Last Update Posted (Actual): January 5, 2022
• Last Update Submitted That Met QC Criteria: January 4, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Immunotherapy; Recurrence; Antineoplastic Agents; Hepatocellular carcinoma; Antineoplastic Agents, Immunological; Transarterial chemoembolization
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Disease Attributes; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Recurrence
• Other Study ID Numbers: BGB-A317-2008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No