Clinical trial · Interventional
A Clinical Study of SH006 Injection in Combination Therapy Versus Regorafenib in the Treatment of Advanced Hepatocellular Carcinoma
A Prospective, Randomized, Active-Controlled, Open-Label, National Multicenter Phase II/III Registration Study of SH006 Injection Combination Therapy Versus Regorafenib in the Treatment of Advanced Hepatocellular Carcinoma
NCT07392866CI-TRIAL-00102793not yet recruitingPhase 2 / Phase 3ClinicalTrials.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 the combination therapy of SH006 injection in the treatment of advanced 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 (HCC) | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Capecitabine | Drug | Capecitabine | ALIAS |
| Oxaliplatin injection | Drug | Oxaliplatin | ALIAS |
| Regorafenib | Drug | Regorafenib | ALIAS |
| SH006 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Arm 1 SH006 in combination with bevacizumab and chemotherapy
- interventionNames
- Drug: SH006
- Drug: Bevacizumab
- Drug: Oxaliplatin injection
- Drug: Capecitabine
- type
- EXPERIMENTAL
- label
- Arm 2 SH006 in combination with bevacizumab
- interventionNames
- Drug: SH006
- Drug: Bevacizumab
- type
- EXPERIMENTAL
- label
- Arm 3 SH006 in combination with chemotherapy
- interventionNames
- Drug: SH006
- Drug: Oxaliplatin injection
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects participate voluntarily and sign informed consent. * Age ≥ 18 and ≤ 75 years old, male or female. * Histological or clinical diagnosis of HCC. * Barcelona Clinic Liver Cancer stage C. BCLC stage B, not suitable for radical surgery and/or local treatment * Previous treatment with a drug containing an immune checkpoint inhibitor failed. * Child-Pugh ≤7 , no history of hepatic encephalopathy. Exclusion Criteria: * Histologically documented fibrolamellar hepatocellular carcinoma, sarcoma-like hepatocellular carcinoma, etc. * History of malignancy other than HCC within 5 years prior to the start of study treatment. * History of liver transplantation, or planned to receive liver transplantation. * Moderate or severe ascites with clinical symptoms that require drainage, uncontrolled or moderate or severe pleural and pericardical effusion. * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. * Involvement of both the main portal vein and the left and right branches by portal vein tumor thrombus, or of both the main trunk and the superior mesenteric vein concurrently, or of inferior vena cava.
References
Publications (0)
Data not yet available
No reference posted for this study.