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

Condition(s) studied

Investigational drug(s) / intervention(s)

SH006: 15 mg/kg administered as IV infusion on Day 1 of each 21-day cycle

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

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

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

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

Study summary

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

Eligibility

Primary outcome measure(s)

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

Trial sites (2)

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