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

Sponsor
Nanjing Sanhome Pharmaceutical, Co., Ltd.
Study ID
NCT07392866
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

  • Hepatocellular Carcinoma (HCC)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

First listed
Feb 6, 2026
Start date
Mar 1, 2026
Status verified
Feb 2026
Primary completion
Mar 1, 2030
Completion
Mar 1, 2030

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1 SH006 in combination with bevacizumab and chemotherapy
  • Experimental: Arm 2 SH006 in combination with bevacizumab
  • Experimental: Arm 3 SH006 in combination with chemotherapy
  • Active Comparator: Arm 4 Regorafenib

Primary Outcome Measure

Progression-free Survival (PFS) (Phase II) [ Time Frame: Up to approximately 4 years ]

Central Contacts

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