NCT07392866Not yet recruitingPhase 2/3
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
Source: ClinicalTrials.gov · Last updated 9 Feb 2026
Brief summary (registry, in English)
To evaluate the efficacy and safety of the combination therapy of SH006 injection in the treatment of advanced hepatocellular carcinoma
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 31 Jan 2026
- Start date
- 1 Mar 2026
- Primary completion date
- 1 Mar 2030
- Lead sponsor
- Nanjing Sanhome Pharmaceutical, Co., Ltd.
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07392866
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 120
- From 1 Mar 2026 to the primary completion date, 1 Mar 2030
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Histologically documented fibrolamellar hepatocellular carcinoma, sarcoma-like hepatocellular carcinoma, etc.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nanjing Tianyinshan Hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Zhongshan Hospital,Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.