A Study to Compare the Effectiveness and Safety of IBI310 Combined With Sintilimab Versus Sorafenib in the First-line Treatment of Advanced HCC
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Sintilimab combined with IBI310
|
Drug: IBI310
IBI310 IV d1, Q6W
Drug: Sintilimab
sintilimab IV d1, Q3W
|
| Active Comparator: Sorafenib
|
Drug: Sorafenib
Sorafenib 400mg po
|
Outcome Measures
Primary Outcome Measures
- Overall survival (OS) [up to 24 months after randomization]
- 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
Secondary Outcome Measures
- 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
- 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
- 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
- The incidence and severity of Treatment-Emergent Adverse Events [up to 24 months after randomization]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Histologically/cytologically confirmed hepatocellular carcinoma, or liver cirrhosis meeting the clinical diagnostic criteria;
-
ECOG performance status score of 0 or 1 point;
-
No systemic antitumor treatment for hepatocellular carcinoma before the first administration;
-
Barcelona Clinic Liver Cancer stage C, or Stage B not suitable for radical surgery and/or local treatment;
-
At least 1 measurable lesion according to RECIST V1.1);
-
Child-Pugh:≤6
-
Adequate organ and bone marrow function.
Exclusion Criteria:
-
With fibrous lamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma components in tumor tissues.
-
Have a history of hepatic encephalopathy or have a history of liver transplantation.
-
With clinical symptoms requires drainage of pleural effusion, ascites or pericardial effusion.
-
Central nervous system (CNS) metastasis.
-
Uncontrolled high blood pressure, systolic blood pressure >140mmHg or diastolic blood pressure >90mmHg after optimal medical treatment.
-
Local treatment for liver lesions within 4 weeks.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fudan Universtiy Zhongshan Hospital | Shanghai | Shanghai | China | 200000 |
Sponsors and Collaborators
- Innovent Biologics (Suzhou) Co. Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CIBI310C301