Hepatocellular Carcinoma
Conditions
Brief summary
This is a randomized, open-label, controlled, multicenter Phase III study to evaluate the effectiveness and safety of IBI310 combined with sintilimab and sorafenib in patients with locally advanced or metastatic HCC who have not previously received systemic therapy, are unsuitable for radical surgical resection or local treatment, or have had progressive disease after surgical resection or local treatment.
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 75 Years
Healthy volunteers
No
Inclusion criteria
1. Histologically/cytologically confirmed hepatocellular carcinoma, or liver cirrhosis meeting the clinical diagnostic criteria; 2. ECOG performance status score of 0 or 1 point; 3. No systemic antitumor treatment for hepatocellular carcinoma before the first administration; 4. Barcelona Clinic Liver Cancer stage C, or Stage B not suitable for radical surgery and/or local treatment; 5. At least 1 measurable lesion according to RECIST V1.1); 6. Child-Pugh:≤6 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 |
|---|---|---|
| Objective response rate (ORR) | up to 24 months after randomization | Objective response rate (ORR) in two arms based on RECIST V1.1 by the IRRC |
| Overall survival (OS) | up to 24 months after randomization | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of response(DOR) | up to 24 months after randomization | Duration of response(DOR) in two arms based on RECIST V1.1 by the IRRC and investigator |
| Disease control rate(DCR) | up to 24 months after randomization | Disease control rate(DCR) in two arms based on RECIST V1.1 by the IRRC and investigator |
| Time to progression(TTP) | up to 24 months after randomization | Time to progression(TTP) in two arms based on RECIST V1.1 by the IRRC and investigator |
| The incidence and severity of Treatment-Emergent Adverse Events | up to 24 months after randomization | — |
| Time to response(TTR) | up to 24 months after randomization | Time to response(TTR) in two arms based on RECIST V1.1 by the IRRC and investigator |
| Progression-free survival (PFS) | up to 24 months after randomization | Progression-free survival (PFS) in two arms based on RECIST V1.1 by the IRRC and investigator |
Countries
China
Outcome results
None listed