Clinical trial NCT05564338: Efficacy and Safety of Sitravatinib Plus Tislelizumab or Placebo Plus Tislelizumab Versus Placebo as Adjuvant Treatment in Participants With Hepatocellular Carcinoma
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Hepatocellular Carcinoma
Keywords: hepatocellular carcinoma
sitravatinib
tislelizumab
Lead sponsor: BeiGene
Sponsor class: INDUSTRY
First posted: 2022-10-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Recurrence-free survival (RFS) as assessed by the investigator between Arm A and Arm D
timeFrame: Up to 2 Years
measure: Recurrence-free survival (RFS) as assessed by the investigator between Arm B and Arm D
timeFrame: Up to 2 Years
Secondary outcomes:
measure: Arm A and Arm B: Recurrence-free survival (RFS)
timeFrame: Up to 2 Years
measure: Arm A and Arm C: Recurrence-free survival (RFS)
timeFrame: Up to 2 Years
measure: Arm A and Arm D: overall survival (OS)
timeFrame: Up to 5 Years
measure: Arm B and Arm D: overall survival (OS)
timeFrame: Up to 5 Years
measure: Arm A and Arm B: overall survival (OS)
timeFrame: Up to 5 Years
measure: Arm A and Arm C: overall survival (OS)
timeFrame: Up to 5 Years
measure: Arm A and Arm D: time to extrahepatic spread (EHS) as assessed by the investigator
timeFrame: Up to 2 Years
measure: Arm B and Arm D: time to extrahepatic spread (EHS) as assessed by the investigator
timeFrame: Up to 2 Years
measure: Arm A and Arm B: time to extrahepatic spread (EHS) as assessed by the investigator
timeFrame: Up to 2 Years
measure: Arm A and Arm C: time to extrahepatic spread (EHS) as assessed by the investigator
timeFrame: Up to 2 Years
measure: Number of participants with adverse events (AEs)
timeFrame: Up to 5 Years
measure: Participants Reported Outcome as measured at Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and its hepatocellular carcinoma cancer module QLQ-HCC18
timeFrame: Up to 2 Years
Other outcomes:
Locations:
Study officials:
References: