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

Hepatocellular Carcinoma Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Compare the Efficacy and Safety of Sitravatinib Plus Tislelizumab or Placebo Plus Tislelizumab Versus Placebo as Adjuvant Treatment in Patients With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Surgical Resection

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05564338
• Other study ID #: BGB-A317-Sitravatinib-303
• Status: Withdrawn
• Phase: Phase 3
• Start date: June 30, 2023
• Est. completion date: April 30, 2028

Study information

• Verified date: June 2023
• Source: BeiGene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 30, 2028
• Est. primary completion date: April 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Sitravatinib
Administered orally
• Tislelizumab
Administered intravenously
• sitravatinib-matching placebo
administered orally
• tislelizumab-matching placebo
administered intravenously

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
BeiGene

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Arm A and Arm B: Recurrence-free survival (RFS)	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	Arm A and Arm C: Recurrence-free survival (RFS)	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	Arm A and Arm D: overall survival (OS)	defined as the time from the date of randomization until the date of death due to any cause	Up to 5 Years
Secondary	Arm B and Arm D: overall survival (OS)	defined as the time from the date of randomization until the date of death due to any cause	Up to 5 Years
Secondary	Arm A and Arm B: overall survival (OS)	defined as the time from the date of randomization until the date of death due to any cause	Up to 5 Years
Secondary	Arm A and Arm C: overall survival (OS)	defined as the time from the date of randomization until the date of death due to any cause	Up to 5 Years
Secondary	Arm A and Arm D: time to extrahepatic spread (EHS) as assessed by the investigator	defined as the time from the date of randomization until the date of the first documented occurrence of extrahepatic HCC	Up to 2 Years
Secondary	Arm B and Arm D: time to extrahepatic spread (EHS) as assessed by the investigator	defined as the time from the date of randomization until the date of the first documented occurrence of extrahepatic HCC	Up to 2 Years
Secondary	Arm A and Arm B: time to extrahepatic spread (EHS) as assessed by the investigator	defined as the time from the date of randomization until the date of the first documented occurrence of extrahepatic HCC	Up to 2 Years
Secondary	Arm A and Arm C: time to extrahepatic spread (EHS) as assessed by the investigator	defined as the time from the date of randomization until the date of the first documented occurrence of extrahepatic HCC	Up to 2 Years
Secondary	Number of participants with adverse events (AEs)	Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (v) 5.0, vital signs, and clinical laboratory test results in the Safety Analysis Set	Up to 5 Years
Secondary	Participants Reported Outcome as measured at Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and its hepatocellular carcinoma cancer module QLQ-HCC18	Quality of Life change with treatment. Scale scores are calculated by averaging items within scales and transforming average scores linearly. All of the scales range in score from 0 to 100	Up to 2 Years