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
Sex
ALL
Min age
18 Years
Max age
75 Years
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:
* 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.
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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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