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

Primary Purpose

Hepatocellular Carcinoma, Adjuvant Therapy

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Tislelizumab
TACE
Sponsored by
Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular carcinoma, Immunotherapy, Transarterial chemoembolization, Recurrence, Antineoplastic Agents, Immunological, Antineoplastic Agents

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • the First Affiliated Hospital, School of Medicine, Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Postoperative TACE + Tislelizumab 200mg IV Q3W

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
July 25, 2021
Last Updated
January 4, 2022
Sponsor
Zhejiang University
Collaborators
First Hospital of China Medical University, Shandong Cancer Hospital and Institute, The Affiliated Hospital Of Southwest Medical University, Hainan People's Hospital, Tianjin Third Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04981665
Brief Title
A Study to Evaluate TACE Sequential Tislelizumab as Adjuvant Therapy in Participants With HCC at High Risk of Recurrence After Curative Resection
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 8, 2021 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang University
Collaborators
First Hospital of China Medical University, Shandong Cancer Hospital and Institute, The Affiliated Hospital Of Southwest Medical University, Hainan People's Hospital, Tianjin Third Central Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma, Adjuvant Therapy
Keywords
Hepatocellular carcinoma, Immunotherapy, Transarterial chemoembolization, Recurrence, Antineoplastic Agents, Immunological, Antineoplastic Agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Postoperative TACE + Tislelizumab 200mg IV Q3W
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Tislelizumab
Other Intervention Name(s)
BGB-A317, Immunotherapy, Anti-PD-1 therapy
Intervention Description
Tislelizumab 200mg IV Q3W
Intervention Type
Drug
Intervention Name(s)
TACE
Other Intervention Name(s)
Transarterial Chemoembolization
Intervention Description
TACE will be performed after curative resection (4±1w)
Primary Outcome Measure Information:
Title
2-year Recurrence Free Survival Rate (2-year RFS rate)
Description
2-year RFS rate is defined as the proportion of patients alive and free of recurrence at 2 years after curative resection.
Time Frame
Observation period 24 months
Secondary Outcome Measure Information:
Title
Recurrence-Free Survival (RFS)
Description
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.
Time Frame
24 months
Title
Time to recurrence (TTR)
Description
TTR is defined as the time from the date of curative resection to the first documented recurrence.
Time Frame
24 months
Title
Overall Survival (OS）
Description
OS is defined as the time from the date of curative resection until death due to any cause.
Time Frame
24 months
Title
1-year RFS rate
Description
1-year RFS rate is defined as the proportion of patients alive and free of recurrence at 1 years after curative resection.
Time Frame
12 months
Title
1-year OS rate/2-year OS rate
Description
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.
Time Frame
12 months/24 months
Title
Adverse Events (AEs)
Description
The grade of AEs and the number of patients with AEs are assessed based on CTCAE v5.0
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tingbo Liang
Phone
+8613666676128
Email
liangtingbo@zju.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Tao Ma
Phone
+8613857148997
Email
zjumatao@zju.edu.cn
Facility Information:
Facility Name
the First Affiliated Hospital, School of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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

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