HAIC Combined With Sintilimab Plus Bevacizumab Biosimilar for Advanced Hepatocellular Carc
To evaluate HAIC combined with Sintilimab plus bevacizumab biosimilar for advanced hepatocellular carcinoma.
| Condition(s) | Hepatocellular Carcinoma (HCC) |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | To evaluate HAIC combined with Sintilimab plus bevacizumab biosimilar for advanced hepatocellular carcinoma. |
| Who can participate | Inclusion Criteria: * Written informed consent obtained. * Age ≥ 18 years at time of study entry. * Barcelona Clinic Liver Cancer stage C, or stage B not amenable to curative or locoregional therapies. * HCC confirmed by radiology, histology or cytology. * No prior systemic therapy for HCC. * At least one measurable site of disease as defined by RECIST1.1criteria with spiral CT scan or MRI. * Child-Pugh scores 5-7, performance status (PS) ≤ 2 (ECOG scale). * Subjects with chronic HBV infection must have HBV DNA viral load \< 100 IU/mL at screening. In addition, they must be on antiviral therapy per regional standard of care guidelines prior to initiation of study therapy. * Life expectancy of at least 12 weeks. * Adequate blood count, liver-enzymes, and renal function: absolute neutrophil c |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Fudan University |
| Locations | Shanghai, Shanghai Municipality, China |
| Start date | 2025-03-18 |
| NCT ID | NCT06860490 |
| Official listing | https://clinicaltrials.gov/study/NCT06860490 |