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

NCT07392866 | Not Yet Recruiting Phase 2

• 1 other identifier: SHS006-II/III-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Hepatocellular Carcinoma (HCC)

Keywords

hepatocellular carcinoma; immune checkpoint inhibitors

Outcome Measures

Primary Outcomes (3)

• Progression-free Survival (PFS) (Phase II)

  PFS was assessed by investigators per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).

  Up to approximately 4 years

• Incidence of Adverse Events (AEs) (Phase II)

  An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.

  Up to approximately 4 years

• Overall Survival (OS) (Phase III)

  OS was defined as the time from randomization to death due to any cause.

  Up to approximately 4 years

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  Up to approximately 4 years

• Disease Control Rate (DCR)

  Up to approximately 4 years

• Duration of Response (DOR)

  Up to approximately 4 years

• Time to progression (TTP)

  Up to approximately 4 years

Study Arms (4)

Arm 1 SH006 in combination with bevacizumab and chemotherapy

EXPERIMENTAL

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

Arm 2 SH006 in combination with bevacizumab

EXPERIMENTAL

Drug: SH006; Drug: Bevacizumab

Arm 3 SH006 in combination with chemotherapy

EXPERIMENTAL

Drug: SH006; Drug: Oxaliplatin injection; Drug: Capecitabine

Arm 4 Regorafenib

ACTIVE COMPARATOR

Drug: Regorafenib

Interventions

SH006 DRUG

15 mg/kg administered as IV infusion on Day 1 of each 21-day cycle

Arm 1 SH006 in combination with bevacizumab and chemotherapy; Arm 2 SH006 in combination with bevacizumab; Arm 3 SH006 in combination with chemotherapy

Bevacizumab DRUG

15 mg/kg administered as IV infusion on Day 1 of each 21-day cycle

Arm 1 SH006 in combination with bevacizumab and chemotherapy; Arm 2 SH006 in combination with bevacizumab

Oxaliplatin injection DRUG

85 mg/m2 administered as IV infusion on Day 1 of each 21-day cycle

Arm 1 SH006 in combination with bevacizumab and chemotherapy; Arm 3 SH006 in combination with chemotherapy

Capecitabine DRUG

1000 mg/m2 orally twice daily for 14 days continuous dosing followed by a 7-day break of each 21-day cycle

Arm 1 SH006 in combination with bevacizumab and chemotherapy; Arm 3 SH006 in combination with chemotherapy

Regorafenib DRUG

160 mg orally once daily for 21 days continuous dosing followed by a 7-day break of each 28-day cycle

Arm 4 Regorafenib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing Sanhome Pharmaceutical, Co., Ltd.: lead

Study Sites (2)

Nanjing Tianyinshan Hospital

Nanjing, Jiangsu, 211199, China

Location

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Bevacizumab; Oxaliplatin; Capecitabine; regorafenib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Jie Min

CONTACT

86-15121121360; minjie@sanhome.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2026
• First Posted: February 6, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): March 1, 2030
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)