Clinical trial · Interventional
Sintilimab Combined With Bevacizumab and Liver Protective Support Therapy in Unresectable Hepatocellular Carcinoma
A Study to Evaluate the Efficacy and Safety of the Sintilimab Combined With Bevacizumab and Liver Protective Support Therapy in Child-Pugh B and/or ECOG PS 2 Unresectable Hepatocellular Carcinoma
NCT05616390CI-TRIAL-00064861unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the efficacy and safety of sintilimab combined with bevacizumab and liver protective support therapy in Child-Pugh B and/or ECOG PS 2 unresectable hepatocellular carcinoma
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Liver Protective Support Therapy | Combination Product | — | UNRESOLVED |
| Sintilimab | Drug | Sintilimab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- experimental group
- description
- Sintilimab Combined With Bevacizumab and Liver Protective Support Therapy
- interventionNames
- Drug: Sintilimab
- Drug: Bevacizumab
- Combination Product: Liver Protective Support Therapy
Primary outcomes (2)
- measure
- Adverse Events (AEs)
- timeFrame
- Up to 3 years
- description
- Defined as the proportion of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0
- measure
- Overall survival (OS)
- timeFrame
- Up to 3 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion Criteria: * Advanced unresectable hepatocellular carcinoma confirmed by histology or cytology * Age 20-79 * At least one measurable lesion defined in RECIST version 1.1 * Child Pugh grade B * ECOG PS score 2 * The expected life is at least 90 days Exclusion Criteria: * Previously received anti-PD-1, PD-L1, PD-L2, CD137, CTLA-4 antibody treatment, or any other treatment that regulates T cells * Received systemic corticosteroid or immunosuppressive therapy within 28 days before enrollment * Complicated with autoimmune diseases or having a history of chronic or recurrent autoimmune diseases * History of pleural or pericardial adhesions within 28 days before enrollment * HIV antibody, HTV-Ⅰantibody, HCV antibody, hepatitis B surface protein antigen, hepatitis B surface protein antibody, hepatitis B core protein antibody or any detectable hepatitis B virus DNA test results were positive * Multiple primary cancers (excluding completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, superficial bladder cancer, and any other cancer that has not recurred for at least 5 years) * Brain or meningeal metastasis (unless asymptomatic and does not require treatment) * Uncontrollable or serious cardiovascular disease.
References
Publications (0)
Data not yet available
No reference posted for this study.