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

NCT05564338 | Withdrawn Phase 3 DMC

• 1 other identifier: BGB-A317-Sitravatinib-303
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Keywords

hepatocellular carcinoma; sitravatinib; tislelizumab

Outcome Measures

Primary Outcomes (2)

• Recurrence-free survival (RFS) as assessed by the investigator between Arm A and Arm D

  RFS is defined as the time from the date of randomization until the date of the first documented occurrence of intrahepatic or extrahepatic hepatocellular carcinoma (HCC) as assessed by the investigator, or death from any cause, whichever occurs first.

  Up to 2 Years

• Recurrence-free survival (RFS) as assessed by the investigator between Arm B and Arm D

  defined as the time from the date of randomization until the date of the first documented occurrence of intrahepatic or extrahepatic hepatocellular carcinoma as assessed by the investigator, or death from any cause, whichever occurs first.

  Up to 2 Years

Secondary Outcomes (12)

• Arm A and Arm B: Recurrence-free survival (RFS)

  Up to 2 Years

• Arm A and Arm C: Recurrence-free survival (RFS)

  Up to 2 Years

• Arm A and Arm D: overall survival (OS)

  Up to 5 Years

• Arm B and Arm D: overall survival (OS)

  Up to 5 Years

• Arm A and Arm B: overall survival (OS)

  Up to 5 Years

Study Arms (4)

Treatment Arm A: sitravatinib + tislelizumab

EXPERIMENTAL

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

Drug: Sitravatinib; Drug: Tislelizumab

Treatment Arm B: Placebo + tislelizumab

EXPERIMENTAL

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

Drug: Tislelizumab; Drug: sitravatinib-matching placebo

Treatment Arm C:Sitravatinib + Placebo

EXPERIMENTAL

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

Drug: Sitravatinib; Drug: tislelizumab-matching placebo

Treatment Arm D: Matching Placebo

EXPERIMENTAL

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

Drug: sitravatinib-matching placebo; Drug: tislelizumab-matching placebo

Interventions

Sitravatinib DRUG

Administered orally

Treatment Arm A: sitravatinib + tislelizumab; Treatment Arm C:Sitravatinib + Placebo

Tislelizumab DRUG

Administered intravenously

Treatment Arm A: sitravatinib + tislelizumab; Treatment Arm B: Placebo + tislelizumab

sitravatinib-matching placebo DRUG

administered orally

Treatment Arm B: Placebo + tislelizumab; Treatment Arm D: Matching Placebo

tislelizumab-matching placebo DRUG

administered intravenously

Treatment Arm C:Sitravatinib + Placebo; Treatment Arm D: Matching Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Participant must have tumor-free status as assessed by the investigator and have fully recovered from surgical resection before randomization
• Participant must have no extrahepatic HCC
• ECOG Performance Status ≤ 1
• Participant who has undergone surgical resection and is defined as having a high risk of HCC recurrence

You may not qualify if:

• Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology
• Evidence of residual, recurrent, or metastatic disease of HCC before randomization
• 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
• Untreated chronic hepatitis B (HBV) or chronic HBV carriers with HBV DNA ≥ 2000 IU/mL at Screening
• Untreated or incompletely treated esophageal or gastric varices with bleeding or high risk of bleeding

Sponsors & Collaborators

• BeiGene: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

sitravatinib; tislelizumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: October 3, 2022
• Study Start: June 30, 2023
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: June 7, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share