Hepatocellular Carcinoma (HCC)
Conditions
Keywords
hepatocellular carcinoma, immune checkpoint inhibitors
Brief summary
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
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
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
85 mg/m2 administered as IV infusion on Day 1 of each 21-day cycle
Sponsors
Nanjing Sanhome Pharmaceutical, Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | Up to approximately 4 years | ORR was assessed by investigators per RECIST 1.1 |
| Disease Control Rate (DCR) | Up to approximately 4 years | DCR was assessed by investigators per RECIST 1.1 |
| Duration of Response (DOR) | Up to approximately 4 years | DOR was assessed by investigators per RECIST 1.1 |
| Time to progression (TTP) | Up to approximately 4 years | TTP was assessed by investigators per RECIST 1.1 |
Countries
China
Contacts
CONTACTJie Min
Outcome results
None listed