Efficacy and Safety of Sitravatinib Plus Tislelizumab or Placebo Plus Tislelizumab Versus Placebo as Adjuvant Treatment in Participants With Hepatocellular Carcinoma
NCT05564338 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL
Last updated 2023-06-07
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
Interventions
- DRUG
-
Sitravatinib
Administered orally
- DRUG
-
Tislelizumab
Administered intravenously
- DRUG
-
sitravatinib-matching placebo
administered orally
- DRUG
-
tislelizumab-matching placebo
administered intravenously
Sponsors & Collaborators
-
BeiGene
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-06-30
- Primary Completion
- 2027-04-30
- Completion
- 2028-04-30
More Related Trials
-
Seocalcitol Versus Placebo in the Adjuvant Treatment of Hepatocellular Carcinoma
NCT00051545 ·Status: TERMINATED ·Phase: PHASE3
-
Tislelizumab Combined With Lenvatinib for Perioperative Treatment of Resectable Primary Hepatocellular Carcinoma
NCT04834986 ·Status: UNKNOWN ·Phase: PHASE2
-
A Phase Ib/II Trial to Evaluate the Safety and Efficacy of QL1706 in Patients With Advanced Hepatocellular Carcinoma
NCT05603039 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
A Study of Atezolizumab Plus Bevacizumab Versus Active Surveillance as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence After Surgical Resection or Ablation
NCT04102098 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Effect of Adjuvant Therapy by Sorafenib, Oxaliplatin and S-1
NCT02129322 ·Status: WITHDRAWN ·Phase: PHASE2
-
A Study of Neoadjuvant Tislelizumab With SBRT in Patients With Resectable Hepatocellular Carcinoma
NCT05185531 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Tislelizumab Consolidation After Liver-Directed Therapy for Hepatocellular Carcinoma
NCT05366829 ·Status: RECRUITING ·Phase: PHASE2
-
Ablation Plus Tislelizumab Versus Ablation Alone for Intrahepatic Recurrent Early Stage HCC
NCT04663035 ·Status: RECRUITING ·Phase: PHASE2
-
Gemcitabine Plus S1 and Tislelizumab in the First Line Therapy of Advanced Biliary Tract Carcinoma
NCT05822453 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Lenvatinib Combined with Tislelizumab and TACE Applied As Neoadjuvant Regimen for the Patients of CNLC Stage IB and IIA Hepatocellular Carcinoma with High-risk Recurrence Factors
NCT05920863 ·Status: RECRUITING ·Phase: PHASE2
-
A Clinical Study of Tislelizumab Combined With TACE and Lenvatinib in the Neoadjuvant Treatment of Resectable HCC
NCT06003673 ·Status: RECRUITING ·Phase: PHASE4
-
Research on Effectiveness and Safety of the Treatment, Hyperthermic Intraperitoneal Chemotherapy Combined With Tislelizumab and Targeted Therapy, That is Used for High-risk Hepatocellular Carcinoma After R0 Resection
NCT05546619 ·Status: UNKNOWN ·Phase: NA
-
Preliminary Antitumor Activity, Safety and Tolerability of Tislelizumab in Combination With Lenvatinib for Hepatocellular Carcinoma
NCT04401800 ·Status: COMPLETED ·Phase: PHASE2
-
Lenvatinib Plus Tislelizumab Versus Lenvatinib Alone in Hepatocellular Carcinoma Previously Treated With Anti-PD1/PD-L1 and Bevacizumab
NCT07047586 ·Status: RECRUITING ·Phase: PHASE2
-
Sintilimab Combined With Lenvatinib Versus HAIC for Perioperative Treatment of Resectable Primary Hepatocellular Carcinoma
NCT05519410 ·Status: UNKNOWN ·Phase: PHASE2
-
A Study to Explore the Reasonable Dosage and Evaluate the Efficacy, Safety and Tolerability of HLX10 and HLX04 with or Without HLX53 in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients.
NCT06349980 ·Status: RECRUITING ·Phase: PHASE2
-
Tislelizumab Plus TKI as Adjuvant Therapy Versus Active Surveillance in Patients With HCC
NCT06059885 ·Status: RECRUITING ·Phase: PHASE2
-
A Pilot Study to Evaluate the Safety of a 3 Weeks Sitagliptin Treatment in HCC Patients Undergoing Liver Resection
NCT02650427 ·Status: COMPLETED ·Phase: PHASE1
-
HAIC or Lenvatinib Combined With Sintilimab for High Recurrence Risk Resectable Solitary Hepatocellular Carcinoma
NCT05621499 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Phase II Study of Moderate-dose Hypofractionated RT Combined With Tislelizumab for HCC With Diffuse Tumor Thrombosis
NCT06233981 ·Status: COMPLETED ·Phase: PHASE2
-
Postoperative Adjuvant Sintilimab in Hepatocellular Carcinoma With Microvascular Invasion
NCT06089369 ·Status: NOT_YET_RECRUITING ·Phase: PHASE3
-
Multinational Phase II Trial to Compare Safety and Efficacy of SIRT (Y-90 Resin Microspheres) Followed by Atezolizumab Plus Bevacizumab, vs SIRT (SIRT-Y90) Followed by Placebo in Locally Advanced HCC Patients
NCT05377034 ·Status: RECRUITING ·Phase: PHASE2
-
Sintilimab Combined With Bevacizumab and Liver Protective Support Therapy in Unresectable Hepatocellular Carcinoma
NCT05616390 ·Status: RECRUITING ·Phase: PHASE2
-
Donafenib Combined With TACE as Adjuvant Therapy of Patients With Hepatocellular Carcinoma
NCT05161143 ·Status: UNKNOWN ·Phase: PHASE2
-
Anlotinib Hydrochloride Capsules Combined With Penpulimab Injection for the Treatment of Hepatocellular Carcinoma at High Risk of Recurrence.
NCT05862337 ·Status: RECRUITING ·Phase: PHASE3