NCT04720716CompletedPhase 3
A Study to Compare the Effectiveness and Safety of IBI310 Combined With Sintilimab Versus Sorafenib in the First-line Treatment of Advanced HCC
A Randomized, Open-label, Controlled, Multicenter Phase III Clinical Study to Compare the Effectiveness and Safety of IBI310 Combined With Sintilimab Versus Sorafenib in the First-line Treatment of Advanced Hepatocellular Carcinoma
Source: ClinicalTrials.gov · Last updated 19 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 344 (actual)
- First submitted
- 13 Jan 2021
- Start date
- 7 Feb 2021
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT04720716
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 344
- From 7 Feb 2021 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Have a history of hepatic encephalopathy or have a history of liver transplantation.
Other
- With fibrous lamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma components in tumor tissues.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fudan Universtiy Zhongshan Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.