Menu
Not yet recruiting NCT07392866

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

Phase II / Phase III Interventional Hepatocellular Carcinoma (HCC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SH006, Bevacizumab, Oxaliplatin injection, Capecitabine.
Who it may be relevant to
Registry conditions: Hepatocellular Carcinoma (HCC). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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

Interventions

  • Drug SH006
    15 mg/kg administered as IV infusion on Day 1 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 Capecitabine
    1000 mg/m2 orally twice daily for 14 days continuous dosing followed by a 7-day break of each 21-day cycle
  • Drug Regorafenib
    160 mg orally once daily for 21 days continuous dosing followed by a 7-day break of each 28-day cycle

Primary outcome measures

  • Progression-free Survival (PFS) (Phase II) [Time frame: Up to approximately 4 years]
  • Incidence of Adverse Events (AEs) (Phase II) [Time frame: Up to approximately 4 years]
  • Overall Survival (OS) (Phase III) [Time frame: Up to approximately 4 years]
Secondary outcome measures (4)
  • Objective Response Rate (ORR) [Time frame: Up to approximately 4 years]
  • Disease Control Rate (DCR) [Time frame: Up to approximately 4 years]
  • Duration of Response (DOR) [Time frame: Up to approximately 4 years]
  • Time to progression (TTP) [Time frame: Up to approximately 4 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 2 centers
  • Nanjing Tianyinshan Hospital — Nanjing
  • Zhongshan Hospital, Fudan University — Shanghai

Identifiers

NCT: NCT07392866 · SHS006-II/III-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗