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

NCT ID: NCT05407519

Last Updated: 2023-03-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-25
• Study Completion Date: 2026-06-30

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.

Conditions

Hepatocellular Carcinoma

Study Design

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

Study Groups

Tislelizumab 200mg IV q3w + Sitravatinib 100mg PO qd

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.

Group Type: EXPERIMENTAL

Tislelizumab + Sitravatinib

Intervention Type: DRUG

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

Interventions

Tislelizumab + Sitravatinib

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Subjects with a histopathological or cytologically diagnosis of HCC

2. Subjects who have undergone a curative resection

3. High risk for HCC recurrence as protocol defined

4. No previous systematic treatment and locoregional therapy for HCC

5. Child-Pugh Score, Class A

6. ECOG performance status 0 or 1

7. Full recovery from surgical resection

8. Adequate organ function

9. Absence of major macrovascular invasion

10. No extrahepatic spread

11. Life expectancy of at least 6 months

Exclusion Criteria

1. Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC

2. Evidence of residual, recurrent, or metastatic disease

3. Known history of serious allergy to any component of tislelizumab or sitravatinib preparations

4. History of hepatic encephalopathy

5. Tumor thrombus in portal vein or superior mesenteric vein or inferior caval vein

6. Portal hypertension with bleeding esophageal or gastric varices within 6 months prior to initiation of treatment

7. Any bleeding or thrombotic disorder within 6 months prior to initiation of treatment

8. Any active malignancy within 2 years prior to the start of treatment

9. Active or history of autoimmune disease

10. Other acute or chronic conditions, psychiatric disorders, or laboratory abnormalities that may increase the risk of study participation

11. Pregnant or lactating women

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Guangxi Medical University

OTHER

Sponsor Role: collaborator

Henan Cancer Hospital

OTHER_GOV

Sponsor Role: collaborator

Anhui Provincial Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

LianxinLiu

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lianxin LIU secretary of the party committee

Role: PRINCIPAL_INVESTIGATOR

Anhui Provincial Hospital

Locations

Anhui province hospital

Hefei, Anhui, China

Site Status: RECRUITING

Countries

China

Central Contacts

Lianxin LIU secretary of the party committee

Role: CONTACT

liulx@ustc.edu.cn

+86 18096656677

Jiabei WANG None

Role: CONTACT

jbwang16@ustc.edu.cn

+86 13895708992

Facility Contacts

Lianxin Liu, M.D.

Role: primary

liulx@ustc.edu.cn

13845159888

Other Identifiers

BGB-Sitra-2001-IIT

Identifier Type: -

Identifier Source: org_study_id