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

BeiGene

Status and phase: Withdrawn; Phase 3

Conditions: Hepatocellular Carcinoma

Treatments: Drug: tislelizumab-matching placebo; Drug: Tislelizumab; Drug: sitravatinib-matching placebo; Drug: Sitravatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT05564338

BGB-A317-Sitravatinib-303

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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

Key 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

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 4 patient groups

Treatment Arm A: sitravatinib + tislelizumab

Experimental group

Description:

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

Treatment:

Drug: Sitravatinib

Drug: Tislelizumab

Treatment Arm B: Placebo + tislelizumab

Experimental group

Description:

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

Treatment:

Drug: Tislelizumab

Drug: sitravatinib-matching placebo

Treatment Arm C:Sitravatinib + Placebo

Experimental group

Description:

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

Treatment:

Drug: Sitravatinib

Drug: tislelizumab-matching placebo

Treatment Arm D: Matching Placebo

Experimental group

Description:

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

Treatment:

Drug: tislelizumab-matching placebo

Drug: sitravatinib-matching placebo