Efficacy and Safety of Sitravatinib Plus Tislelizumab or Placebo Plus Tislelizumab Versus Placebo as Adjuvant Treatment in Participants With Hepatocellular Carcinoma

NCT ID: NCT05564338

Last Updated: 2023-06-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-30
• Study Completion Date: 2028-04-30

Brief Summary

The purpose of this study is to compare the efficacy and safety of sitravatinib plus tislelizumab or placebo plus tislelizumab versus placebo. The study will also compare the recurrence-free survival (RFS) in participants with hepatocellular carcinoma (HCC) who are at high risk of recurrence after surgical resection.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment Arm A: sitravatinib + tislelizumab

sitravatinib once daily and tislelizumab once every 6 weeks, for up to 17 cycles (approximately 2 years)

Group Type: EXPERIMENTAL

Sitravatinib

Intervention Type: DRUG

Administered orally

Tislelizumab

Intervention Type: DRUG

Administered intravenously

Treatment Arm B: Placebo + tislelizumab

sitravatinib-matching placebo once daily and tislelizumab once every 6 weeks, for up to 17 cycles (approximately 2 years)

Group Type: EXPERIMENTAL

Tislelizumab

Intervention Type: DRUG

Administered intravenously

sitravatinib-matching placebo

Intervention Type: DRUG

administered orally

Treatment Arm C:Sitravatinib + Placebo

sitravatinib once daily and tislelizumab-matching placebo once every 6 weeks, for up to 17 cycles (approximately 2 years)

Group Type: EXPERIMENTAL

Sitravatinib

Intervention Type: DRUG

Administered orally

tislelizumab-matching placebo

Intervention Type: DRUG

administered intravenously

Treatment Arm D: Matching Placebo

sitravatinib-matching placebo once daily and tislelizumab-matching placebo once every 6 weeks, for up to 17 cycles (approximately 2 years)

Group Type: EXPERIMENTAL

sitravatinib-matching placebo

Intervention Type: DRUG

administered orally

tislelizumab-matching placebo

Intervention Type: DRUG

administered intravenously

Interventions

Sitravatinib

Administered orally

Intervention Type: DRUG

Tislelizumab

Administered intravenously

Intervention Type: DRUG

sitravatinib-matching placebo

administered orally

Intervention Type: DRUG

tislelizumab-matching placebo

administered intravenously

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Participant with a first diagnosis of HCC must have undergone a curative-intent resection within 4 to 12 weeks before randomization and have a documented histological confirmation of HCC diagnosis and negative surgical margins (R0 resection) of the resected tumor

2. Participant must have tumor-free status as assessed by the investigator and have fully recovered from surgical resection before randomization

3. Participant must have no extrahepatic HCC

4. ECOG Performance Status ≤ 1

5. Participant who has undergone surgical resection and is defined as having a high risk of HCC recurrence

Exclusion Criteria

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

2. Evidence of residual, recurrent, or metastatic disease of HCC before randomization

3. Major macrovascular (gross vascular) invasion of the portal vein (Vp3 or Vp4) or any grade of macrovascular invasion in the hepatic vein or inferior vena cava

4. Untreated chronic hepatitis B (HBV) or chronic HBV carriers with HBV DNA ≥ 2000 IU/mL at Screening

5. Untreated or incompletely treated esophageal or gastric varices with bleeding or high risk of bleeding

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

Sponsors

BeiGene

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

BGB-A317-Sitravatinib-303

Identifier Type: -

Identifier Source: org_study_id