Clinical trial · Interventional
Efficacy and Safety of Sitravatinib Plus Tislelizumab or Placebo Plus Tislelizumab Versus Placebo as Adjuvant Treatment in Participants With Hepatocellular Carcinoma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study has voluntarily discontinued due to a change in the company-level development strategy and is not because of any safety concern or the request from any health authority worldwide.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sitravatinib | Drug | — | UNRESOLVED |
| sitravatinib-matching placebo | Drug | — | UNRESOLVED |
| Tislelizumab | Drug | Tislelizumab | ALIAS |
| tislelizumab-matching placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Treatment Arm A: sitravatinib + tislelizumab
- description
- sitravatinib once daily and tislelizumab once every 6 weeks, for up to 17 cycles (approximately 2 years)
- interventionNames
- Drug: Sitravatinib
- Drug: Tislelizumab
- type
- EXPERIMENTAL
- label
- Treatment Arm B: Placebo + tislelizumab
- description
- sitravatinib-matching placebo once daily and tislelizumab once every 6 weeks, for up to 17 cycles (approximately 2 years)
- interventionNames
- Drug: Tislelizumab
- Drug: sitravatinib-matching placebo
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available