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Not yet recruitingNCT07392866Updated Feb 9, 2026

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

A Phase 2/3 interventional study of SH006 and Bevacizumab in Hepatocellular Carcinoma (HCC), sponsored by Nanjing Sanhome Pharmaceutical, Co., Ltd.. Not yet recruiting at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-02-09.

Sponsored by Nanjing Sanhome Pharmaceutical, Co., Ltd. · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Hepatocellular Carcinoma (HCC)

Keywords

  • hepatocellular carcinoma
  • immune checkpoint inhibitors
03

In context

Carcinoma, Hepatocellular

3,182 studies on the registry are indexed under Carcinoma, Hepatocellular; 954 are open to participants now.

This study's planned enrollment of 120 is above the median of 55 across 2,298 interventional studies indexed under Carcinoma, Hepatocellular.

Browse Carcinoma, Hepatocellular studies →

Lead sponsor

Nanjing Sanhome Pharmaceutical, Co., Ltd. is the lead sponsor of 23 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Arm 1 SH006 in combination with bevacizumab and chemotherapy

    Drug: SH006 · Drug: Bevacizumab · Drug: Oxaliplatin injection · Drug: Capecitabine

  • Experimental
    Arm 2 SH006 in combination with bevacizumab

    Drug: SH006 · Drug: Bevacizumab

  • Experimental
    Arm 3 SH006 in combination with chemotherapy

    Drug: SH006 · Drug: Oxaliplatin injection · Drug: Capecitabine

  • Active comparator
    Arm 4 Regorafenib

    Drug: Regorafenib

Interventions

  • DrugSH006

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

  • DrugBevacizumab

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

  • DrugOxaliplatin injection

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

  • DrugCapecitabine

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

  • DrugRegorafenib

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

06

What researchers measure

Primary outcomes

  1. Progression-free Survival (PFS) (Phase II)

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

    Time frame: Up to approximately 4 years

  2. 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.

    Time frame: Up to approximately 4 years

  3. Overall Survival (OS) (Phase III)

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

    Time frame: Up to approximately 4 years

Secondary outcomes

  1. Objective Response Rate (ORR)

    ORR was assessed by investigators per RECIST 1.1

    Time frame: Up to approximately 4 years

  2. Disease Control Rate (DCR)

    DCR was assessed by investigators per RECIST 1.1

    Time frame: Up to approximately 4 years

  3. Duration of Response (DOR)

    DOR was assessed by investigators per RECIST 1.1

    Time frame: Up to approximately 4 years

  4. Time to progression (TTP)

    TTP was assessed by investigators per RECIST 1.1

    Time frame: Up to approximately 4 years

07

Study locations

2 sites
  • Nanjing Tianyinshan Hospital
    Nanjing, Jiangsu 211199, China
    • Shukui Qin · Contact · qinsk81@163.com · 86-13905158713
    • Shukui Qin · Principal investigator
  • Zhongshan Hospital, Fudan University
    Shanghai, Shanghai Municipality 200032, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07392866
Lead sponsor
Nanjing Sanhome Pharmaceutical, Co., Ltd.
Responsible party
Sponsor
First posted
Feb 6, 2026
Start date
Mar 1, 2026 (estimated)
Primary completion
Mar 1, 2030 (estimated)
Completion
Mar 1, 2030 (estimated)
Last update
Feb 9, 2026

Study contacts

Jie Min
Contact
minjie@sanhome.com
86-15121121360

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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