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

Primary Purpose

Hepatocellular Carcinoma

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Tislelizumab + Sitravatinib

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - 70 Years (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 component of tislelizumab or sitravatinib preparations
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
Pregnant or lactating women

Sites / Locations

Anhui province hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tislelizumab 200mg IV q3w + Sitravatinib 100mg PO qd

Arm Description

Tislelizumab 200mg IV q3w + Sitravatinib 100mg PO qd Tislelizumab and Sitravatinib will be administered until the disease recurrence, intolerable toxicity, death, withdrawal of consent or completion of 17 cycles of Tislelizumab.

Outcomes

Primary Outcome Measures

RFS rate

2-year Recurrence Free Survival Rate (2-year RFS rate) [Time Frame: Observation period 24 months] 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

TTR

1.Time to recurrence (TTR) [Time Frame: 24 months] TTR is defined as the time from the date of curative resection to the first documented recurrence.

RFS

2.Recurrence-Free Survival (RFS) [Time Frame: 24 months] RFS is defined as the time from the date of curative resection to the first documented recurrenceor death due to any cause, whichever occurs first.

RFS rate

3.1-year RFS rate [Time Frame: 12 months] 1-year RFS rate is defined as the proportion of patients alive and free of recurrence at 1 yearsafter curative resection.

4.Overall Survival (OS）[Time Frame: 24 months] OS is defined as the time from the date of curative resection until death due to any cause.

OS rate

5.1-year OS rate/2-year OS rate [Time Frame: 12 months/24 months] OS rate is defined as the proportion of patients who have not experienced death from any causeat 12 and 24 months after curative resection.

AEs

6.Adverse Events (AEs) [ Time Frame: 24 months ] The grade of AEs and the number of patients with AEs are assessed based on CTCAE v5.0

Full Information

NCT ID

NCT05407519

First Posted

May 30, 2022

Last Updated

March 20, 2023

Sponsor

Anhui Provincial Hospital

Collaborators

First Affiliated Hospital Xi'an Jiaotong University, First Affiliated Hospital of Guangxi Medical University, Henan Cancer Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05407519

Brief Title

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

Official Title

A Open-Label, Multi-Center, Single Arm Study to Evaluate the Efficacy and Safety of Tislelizumab Combined With Sitravatinib 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

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 25, 2022 (Actual)

Primary Completion Date

June 30, 2026 (Anticipated)

Study Completion Date

June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Anhui Provincial Hospital

Collaborators

First Affiliated Hospital Xi'an Jiaotong University, First Affiliated Hospital of Guangxi Medical University, Henan Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

This is an open label, multi-center, single arm study to evaluate the efficacy and safety of tislelizumab combined with sitravatinib 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. Various adjuvant treatment methods including immunotherapy, targeted therapy, TACE are being studied. This study is to explore the efficacy and safety of tislelizumab combined with sitravatinib 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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Tislelizumab 200mg IV q3w + Sitravatinib 100mg PO qd

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Tislelizumab + Sitravatinib

Intervention Description

Drug: Tislelizumab Tislelizumab 200mg IV q3w Other Names: BGB-A317, Immunotherapy, Anti-PD-1 antibody Drug: Sitravatinib Sitravatinib 100mg PO qd Other Name: tyrosine kinase inhibitor, TKI

Primary Outcome Measure Information:

Title

RFS rate

Description

Time Frame

Observation period 24 months

Secondary Outcome Measure Information:

Title

TTR

Description

1.Time to recurrence (TTR) [Time Frame: 24 months] TTR is defined as the time from the date of curative resection to the first documented recurrence.

Time Frame

24 months

Title

RFS

Description

Time Frame

24 months

Title

RFS rate

Description

3.1-year RFS rate [Time Frame: 12 months] 1-year RFS rate is defined as the proportion of patients alive and free of recurrence at 1 yearsafter curative resection.

Time Frame

12 months

Title

Description

4.Overall Survival (OS）[Time Frame: 24 months] OS is defined as the time from the date of curative resection until death due to any cause.

Time Frame

24 months

Title

OS rate

Description

Time Frame

12 months/24 months

Title

AEs

Description

6.Adverse Events (AEs) [ Time Frame: 24 months ] 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

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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 component of tislelizumab or sitravatinib preparations 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 Pregnant or lactating women

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lianxin LIU secretary of the party committee

Phone

+86 18096656677

liulx@ustc.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Jiabei WANG None

Phone

+86 13895708992

jbwang16@ustc.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lianxin LIU secretary of the party committee

Organizational Affiliation

Anhui Provincial Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Anhui province hospital

City

Hefei

State/Province

Anhui

ZIP/Postal Code

230000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lianxin Liu, M.D.

Phone

13845159888

liulx@ustc.edu.cn

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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