A Clinical Study of SH006 Injection in Combination Therapy Versus Regorafenib in the Treatment of Advanced Hepatocellular Carcinoma

Sanhome Pharmaceutical

Status and phase: Begins enrollment this month; Phase 3; Phase 2

Conditions: Hepatocellular Carcinoma (HCC)

Treatments: Drug: Capecitabine; Drug: Oxaliplatin injection; Drug: SH006; Drug: Bevacizumab; Drug: Regorafenib

Study type: Interventional

Funder types: Industry

Identifiers

NCT07392866

SHS006-II/III-01

Details and patient eligibility

About

To evaluate the efficacy and safety of the combination therapy of SH006 injection in the treatment of advanced hepatocellular carcinoma

Full description

This is an open, randomized, multicenter study aimed at evaluating the safety and efficacy of SH006 injection (15 mg/kg) in combination with bevacizumab and/or oxaliplatin/capecitabine versus regorafenib in the treatment of patients with advanced hepatocellular carcinoma

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 4 patient groups

Arm 1 SH006 in combination with bevacizumab and chemotherapy

Experimental group

Treatment:

Drug: Bevacizumab

Drug: SH006

Drug: Oxaliplatin injection

Drug: Capecitabine

Arm 2 SH006 in combination with bevacizumab

Experimental group

Treatment:

Drug: Bevacizumab

Drug: SH006

Arm 3 SH006 in combination with chemotherapy

Experimental group

Treatment:

Drug: SH006

Drug: Oxaliplatin injection

Drug: Capecitabine

Arm 4 Regorafenib

Active Comparator group

Treatment:

Drug: Regorafenib