Hepatocellular CarcinomaPhase 3NCT04720716
A Study to Compare the Effectiveness and Safety of IBI310 Combined With Sintilimab Versus Sorafenib in the First-line Treatment of Advanced HCC
A Phase 3 study testing IBI310, Sintilimab and Sorafenib in people with Hepatocellular Carcinoma, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- IBI310, Sintilimab and Sorafenib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 344 participants
- Where
- 1 siteChina
- Study dates
- 7 Feb 2021to 31 Dec 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan Universtiy Zhongshan Hospital
Shanghai, Shanghai Municipality, 200000
About this study
Official title: 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
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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- IBI310, Sintilimab, Sorafenib
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI310Drug
IBI310 IV d1, Q6W
SintilimabDrug
sintilimab IV d1, Q3W
SorafenibDrug
Sorafenib 400mg po
| Study group | Role | What they receive |
|---|---|---|
| Sintilimab combined with IBI310 | Experimental | Not described Receives: Drug: IBI310; Drug: Sintilimab |
| Sorafenib | Active comparator | Not described Receives: Drug: Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Measured: up to 24 months after randomization
Objective response rate (ORR)
Objective response rate (ORR) in two arms based on RECIST V1.1 by the IRRC
Measured: up to 24 months after randomization
Secondary outcomes (6)
Progression-free survival (PFS)
Progression-free survival (PFS) in two arms based on RECIST V1.1 by the IRRC and investigator
Measured: up to 24 months after randomization
Duration of response(DOR)
Duration of response(DOR) in two arms based on RECIST V1.1 by the IRRC and investigator
Measured: up to 24 months after randomization
Disease control rate(DCR)
Disease control rate(DCR) in two arms based on RECIST V1.1 by the IRRC and investigator
Measured: up to 24 months after randomization
Time to progression(TTP)
Time to progression(TTP) in two arms based on RECIST V1.1 by the IRRC and investigator
Measured: up to 24 months after randomization
Time to response(TTR)
Time to response(TTR) in two arms based on RECIST V1.1 by the IRRC and investigator
Measured: up to 24 months after randomization
The incidence and severity of Treatment-Emergent Adverse Events
Measured: up to 24 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start7 Feb 2021
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 344 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04720716
- Sponsor's protocol ID
- CIBI310C301
- Status last verified
- Mar 2026
- First submitted
- 13 Jan 2021
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04720716
- Acronym / sponsor ID
- CIBI310C301
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 344 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Feb 2021 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sintilimab combined with IBI310 | Experimental | Drug: IBI310, Drug: Sintilimab |
| Sorafenib | Active comparator | Drug: Sorafenib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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);
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IBI310IBI310 IV d1, Q6W | Drug | Sintilimab combined with IBI310 |
| Sintilimabsintilimab IV d1, Q3W | Drug | Sintilimab combined with IBI310 |
| SorafenibSorafenib 400mg po | Drug | Sorafenib |
Primary outcome
Overall survival (OS)
Time frame: up to 24 months after randomization
Objective response rate (ORR)
Time frame: up to 24 months after randomization
Objective response rate (ORR) in two arms based on RECIST V1.1 by the IRRC
6 secondary outcomes
Progression-free survival (PFS)
Time frame: up to 24 months after randomization
Duration of response(DOR)
Time frame: up to 24 months after randomization
Disease control rate(DCR)
Time frame: up to 24 months after randomization
Time to progression(TTP)
Time frame: up to 24 months after randomization
Time to response(TTR)
Time frame: up to 24 months after randomization
The incidence and severity of Treatment-Emergent Adverse Events
Time frame: up to 24 months after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IBI310, Sintilimab and Sorafenib in people with Hepatocellular Carcinoma, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: up to 24 months after randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.