Clinical trial · Interventional
ZG005 Plus Bevacizumab vs Sintilimab Plus Bevacizumab as First-Line Therapy for Advanced Hepatocellular
A Phase 3, Randomized, Open-Label, Active-Controlled, Multicenter Study of ZG005 in Combination With Bevacizumab Versus Sintilimab in Combination With Bevacizumab in the First-Line Treatment of Advanced Hepatocellular Carcinoma
NCT07813572CI-TRIAL-00126199not yet recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260911-000001
Summary
Brief summary (as posted)
The purpose of the study is to evaluate the efficacy of ZG005 combined with bevacizumab compared with sintilimab combined with bevacizumab in the first-line treatment of participants with advanced HCC
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 |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Bevacizumab ( Avastin) | Drug | Bevacizumab | ALIAS |
| Sintilimab | Drug | Sintilimab | ALIAS |
| ZG005 for Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ZG005+Bevacizumab
- description
- ZG005 20 mg/kg administered intravenously every 3 weeks (Q3W) + Bevacizumab(Avastin) 15 mg/kg administered intravenously Q3W
- interventionNames
- Drug: ZG005 for Injection
- Drug: Bevacizumab ( Avastin)
- type
- ACTIVE_COMPARATOR
- label
- Sintilimab Plus Bevacizumab
- description
- Sintilimab 200 mg administered intravenously Q3W + Bevacizumab (达攸同) 15 mg/kg administered intravenouslyQ3W
- interventionNames
- Drug: Sintilimab
- Drug: Bevacizumab
Primary outcomes (2)
- measure
- Progression-free survival (PFS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants with histologically/cytologically confirmed unresectable or metastatic advanced HCC; * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. * Barcelona Clinic Liver Cancer stage B, not suitable for local treatment and BCLC C. * At least one measurable lesion based on Recist1.1. * No prior systemic therapy for HCC. * Child-Pugh ≤6 , no history of hepatic encephalopathy. Exclusion Criteria: * Active Central nervous system (CNS) metastasis or leptomeningeal metastases. * Any condition that is not suitable for participate in this study as determined by investigator.
References
Publications (0)
Data not yet available
No reference posted for this study.