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

February 5, 2026 updated by: Nanjing Sanhome Pharmaceutical, Co., Ltd.

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 211199
        • Nanjing Tianyinshan Hospital
        • Principal Investigator:
          • Shukui Qin
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Zhongshan Hospital, Fudan University
        • Principal Investigator:
          • Jian Zhou
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1 SH006 in combination with bevacizumab and chemotherapy
Drug: Capecitabine
1000 mg/m2 orally twice daily for 14 days continuous dosing followed by a 7-day break of each 21-day cycle
Drug: Bevacizumab
15 mg/kg administered as IV infusion on Day 1 of each 21-day cycle
Drug: Oxaliplatin injection
85 mg/m2 administered as IV infusion on Day 1 of each 21-day cycle
Drug: SH006
15 mg/kg administered as IV infusion on Day 1 of each 21-day cycle
Experimental: Arm 2 SH006 in combination with bevacizumab
Drug: Bevacizumab
15 mg/kg administered as IV infusion on Day 1 of each 21-day cycle
Drug: SH006
15 mg/kg administered as IV infusion on Day 1 of each 21-day cycle
Experimental: Arm 3 SH006 in combination with chemotherapy
Drug: Capecitabine
1000 mg/m2 orally twice daily for 14 days continuous dosing followed by a 7-day break of each 21-day cycle
Drug: Oxaliplatin injection
85 mg/m2 administered as IV infusion on Day 1 of each 21-day cycle
Drug: SH006
15 mg/kg administered as IV infusion on Day 1 of each 21-day cycle
Active Comparator: Arm 4 Regorafenib
Drug: Regorafenib
160 mg orally once daily for 21 days continuous dosing followed by a 7-day break of each 28-day cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Events (AEs) (Phase II)
Time Frame: Up to approximately 4 years
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)
Time Frame: Up to approximately 4 years
OS was defined as the time from randomization to death due to any cause.
Up to approximately 4 years
Progression-free Survival (PFS) (Phase II)
Time Frame: Up to approximately 4 years
PFS was assessed by investigators per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
Up to approximately 4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: Up to approximately 4 years
ORR was assessed by investigators per RECIST 1.1
Up to approximately 4 years
Disease Control Rate (DCR)
Time Frame: Up to approximately 4 years
DCR was assessed by investigators per RECIST 1.1
Up to approximately 4 years
Duration of Response (DOR)
Time Frame: Up to approximately 4 years
DOR was assessed by investigators per RECIST 1.1
Up to approximately 4 years
Time to progression (TTP)
Time Frame: Up to approximately 4 years
TTP was assessed by investigators per RECIST 1.1
Up to approximately 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing Sanhome Pharmaceutical, Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

March 1, 2030

Study Completion (Estimated)

March 1, 2030

Study Registration Dates

First Submitted

January 31, 2026

First Submitted That Met QC Criteria

January 31, 2026

First Posted (Actual)

February 6, 2026

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHS006-II/III-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatocellular Carcinoma (HCC)

Clinical Trials on Capecitabine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe