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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04981665
• Other study ID #: BGB-A317-2008
• Status: Recruiting
• Phase: Phase 2
• Start date: November 8, 2021
• Est. completion date: December 2024

Study information

• Verified date: January 2022
• Source: Zhejiang University
• Contact: Tingbo Liang
• Phone: +8613666676128
• Email: liangtingbo[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adjuvant Therapy
• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Recurrence

Intervention

Drug:
• Tislelizumab
Tislelizumab 200mg IV Q3W
• TACE
TACE will be performed after curative resection (4±1w)

Locations

Country	Name	City	State
China	the First Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (6)

Lead Sponsor	Collaborator
Zhejiang University	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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Time to recurrence (TTR)	TTR is defined as the time from the date of curative resection to the first documented recurrence.	24 months
Secondary	Overall Survival (OS)	OS is defined as the time from the date of curative resection until death due to any cause.	24 months
Secondary	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
Secondary	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
Secondary	Adverse Events (AEs)	The grade of AEs and the number of patients with AEs are assessed based on CTCAE v5.0	24 months