Hepatocellular Carcinoma
Conditions
Brief summary
The purpose of the study is to assess the safety, tolerability and effectiveness of Sintilimab in combination with IBI305 in patients with HCC as the first-line treatment compared with Sorafenib. This study is a randomised, Open-label，Multi-center Study. The primary endpoint is overall survival.
Interventions
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Hepatocellular carcinoma confirmed by histology/cytology. Cirrhosis meets the clinical diagnostic criteria for hepatocellular carcinoma of the American Association for the Diagnosis of Liver Diseases (AASLD). 2. ECOG performance status between 0 and 1 3. No systematic anti-tumor treatment has been performed.(End of postoperative adjuvant chemotherapy for more than 6 months allowed). 4. Barcelona Clinic Liver Cancer stage C. BCLC stage B, not suitable for radical surgery and/or local treatment. 5. At least 1 lesion with measurable disease at baseline by RECIST V1.1. 6. Child-Pugh: \<=7 7. Adequate organ and bone marrow function.
Exclusion criteria
1. With fibrous lamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma components in tumor tissues. 2. Have a history of hepatic encephalopathy or have a history of liver transplantation. 3. With clinical symptoms requires drainage of pleural effusion, ascites or pericardial effusion. 4. Central nervous system (CNS) metastasis. 5. Uncontrolled high blood pressure, systolic blood pressure \>140mmHg or diastolic blood pressure \>90mmHg after optimal medical treatment. 6. Local treatment for liver lesions within 4 weeks.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | up to 24 months after randomization | — |
| Progression-free survival (PFS) | up to 24 months after randomization | Progression-free survival (PFS) in two arms based on RECIST V1.1 by Independent Radiological Review Committee, IRRC. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease control rate (DCR) | up to 24 months after randomization | DCR in two arms based on RECIST V1.1 by IRRC and investigator. |
| Duration of response (DOR) | up to 24 months after randomization | DOR in two arms based on RECIST V1.1 by IRRC and investigator. |
| Time to progression (TTP) | One assessment was performed every 6 weeks (±7 days) from the time of randomization, and once every 12 weeks (±7 days) after 48 weeks. | TTP in two arms based on RECIST V1.1 by IRRC and investigator. |
| PFS | up to 24 months after randomization | PFS in two arms based on RECIST V1.1 by investigator. |
| Anti-drug antibody (ADA) | up to 24 months after randomization | Immunogenicity measured by anti-drug antibody (ADA) for Sintilimab and IBI305. |
| EORTC QLQ-C30 | up to 24 months after randomization | — |
| EORTC QLQ-HCC18 | up to 24 months after randomization | — |
| Time to response (TTR) | up to 24 months after randomization | TTR in two arms based on RECIST V1.1 by IRRC and investigator. |
| Objective response rate (ORR) | up to 24 months after randomization | Objective response rate (ORR) in two arms based on RECIST V1.1 by IRRC and investigator . |
Countries
China
Outcome results
None listed