Resectable Hepatocellular CarcinomaPhase 1/2NCT07714317
Phase Ib/II Multicenter Randomized Control Study of Peri-operative Treatment With Combination of CTLA-4, PD-1 Antibodies and Bevacizumab in Resectable HCC (Prophet)
A Phase 1/2 study testing IBI310+ sintilimab + bevacizumab, IBI310+ sintilimab and sintilimab + bevacizumab in people with Resectable Hepatocellular Carcinoma, run by Shanghai Zhongshan Hospital.
Trial summary
The purpose of this phase Ib/II multicenter randomized control study is to investigate the efficacy and safety of peri-operative treatment with combination of CTLA-4, PD-1 antibodies and bevacizumab in resectable HCC Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Resectable Hepatocellular Carcinoma
- What is being tested?
- IBI310+ sintilimab + bevacizumab, IBI310+ sintilimab and sintilimab + bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 20 Jul 2026to 31 May 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- Written informed consent shall be obtained prior to any trial-related procedures.
- Male or female patients aged ≥18 years and ≤75 years.
- Initial resectable hepatocellular carcinoma (HCC) confirmed by imaging, pathology or cytology.
- No macrovascular tumor thrombus or extrahepatic metastasis detected on imaging examinations.
- Single intrahepatic tumor >5 cm in diameter, or 2-3 intrahepatic tumors with no restriction on tumor diameter (corresponding to CNLC stage Ib-IIa of primary liver cancer in China).
- The maximum tumor diameter < 8 cm.
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- Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.
- Child-Pugh Class A liver function.
- No prior systemic therapy or locoregional therapy for HCC; patients with recurrence ≥2 years after previous curative surgical resection or ablation are eligible for enrollment.
- At least one measurable lesion per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
- Adequate organ function.
Who cannot join
- Histologically or cytologically confirmed tumors containing components of fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, or other mixed subtypes.
- History of hepatic encephalopathy or prior liver transplantation.
- Currently participating in an interventional clinical trial, or received any investigational medicinal product or investigational device within 4 weeks prior to the first study drug administration.
- Prior receipt of any of the following therapies: anti-PD-1, anti-PD-L1, anti-PD-L2 agents, or agents targeting other T-cell co-stimulatory or co-inhibitory receptors (including but not limited to CTLA-4, OX-40, CD137).
- Received systemic therapy with Chinese patent medicines with anti-tumor indications or immunomodulatory agents (including thymopeptides, interferons, interleukins; excluding local intrapleural administration for controlling pleural effusion) within 2 weeks prior to the first study drug administration.
- History of active autoimmune disease requiring systemic therapy (e.g., disease-modifying agents, corticosteroids, immunosuppressants) within 2 years before the first study drug administration. Replacement therapies (e.g., thyroxine, insulin, physiologic corticosteroids for adrenal or pituitary insufficiency) shall not be regarded as systemic treatment.
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- Receiving systemic corticosteroid therapy (excluding intranasal, inhaled, or other locally administered corticosteroids) or any other form of immunosuppressive therapy within 7 days prior to the first study drug administration.
- Note: Physiologic doses of corticosteroids (≤10 mg prednisone equivalent per day) are permitted.
- Known history of allogeneic solid organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation.
- Known hypersensitivity to any study drug used in this trial.
- Have not fully recovered from toxicities and/or complications induced by any prior intervention before study treatment initiation.
- Known history of human immunodeficiency virus (HIV) infection.
- Untreated active hepatitis B virus (HBV) infection.
- Subjects with active hepatitis C virus (HCV) infection.
- Received any live vaccine within 30 days prior to the first study drug administration (Day 1 of Cycle 1).
- Pregnant or lactating women.
- Presence of any severe or uncontrolled systemic disease.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The purpose of this phase Ib/II multicenter randomized control study is to investigate the efficacy and safety of peri-operative treatment with combination of CTLA-4, PD-1 antibodies and bevacizumab in resectable HCC
Read the detailed description
This study is a prospective, national multi-center clinical trial. Patients with initially resectable hepatocellular carcinoma were randomly assigned to receive neoadjuvant therapy in three groups: IBI310+ sintilimab + bevacizumab (Group A), IBI310+ sintilimab (Group B), and Sintilimab + bevacizumab (Group C).
- Conditions
- Resectable Hepatocellular Carcinoma
- Being tested
- IBI310+ sintilimab + bevacizumab, IBI310+ sintilimab, sintilimab + bevacizumab
- Keywords
- peri-operative treatment, hepatocellular carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI310+ sintilimab + bevacizumabDrug
systemic therapy
IBI310+ sintilimabDrug
systemic therapy
sintilimab + bevacizumabDrug
systemic therapy
| Study group | Role | What they receive |
|---|---|---|
| IBI310+ sintilimab + bevacizumab | Experimental | Not described Receives: Drug: IBI310+ sintilimab + bevacizumab |
| IBI310+ sintilimab | Experimental | Not described Receives: Drug: IBI310+ sintilimab |
| sintilimab + bevacizumab | Experimental | Not described Receives: Drug: sintilimab + bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average depth of pathological response
Pathological response depth is defined as the proportion of non-viable tumors in surgical specimens to the total sample after neoadjuvant therapy. The average pathological response depth is defined as the average value of the pathological response depth.
Measured: 6 months
Secondary outcomes (2)
1y-RFS rate
The proportion of patients without disease recurrence or death within 1 year following the second randomization
Measured: 12 months
1y-EFS rate
The proportion of patients without disease progression precluding surgical resection, post-operative disease recurrence, or death within 1 year after the first randomization
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start20 Jul 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Hepatocellular CarcinomaStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07714317
- Sponsor's protocol ID
- Prophet-IBI310
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib/II Multicenter Randomized Control Study of Peri-operative Treatment With Combination of CTLA-4, PD-1 Antibodies and Bevacizumab in Resectable HCC (Prophet)
- ClinicalTrials.gov ID
- NCT07714317
- Acronym / sponsor ID
- Prophet-IBI310
- Conditions
- Resectable Hepatocellular Carcinoma
- Keywords
- peri-operative treatment, hepatocellular carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 20 Jul 2026 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 May 2030 (estimated)
- First posted
- 20 Jul 2026 (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.
The purpose of this phase Ib/II multicenter randomized control study is to investigate the efficacy and safety of peri-operative treatment with combination of CTLA-4, PD-1 antibodies and bevacizumab in resectable HCC
Detailed description
This study is a prospective, national multi-center clinical trial. Patients with initially resectable hepatocellular carcinoma were randomly assigned to receive neoadjuvant therapy in three groups: IBI310+ sintilimab + bevacizumab (Group A), IBI310+ sintilimab (Group B), and Sintilimab + bevacizumab (Group C).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IBI310+ sintilimab + bevacizumab | Experimental | Drug: IBI310+ sintilimab + bevacizumab |
| IBI310+ sintilimab | Experimental | Drug: IBI310+ sintilimab |
| sintilimab + bevacizumab | Experimental | Drug: sintilimab + bevacizumab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Written informed consent shall be obtained prior to any trial-related procedures.
- Male or female patients aged ≥18 years and ≤75 years.
- Initial resectable hepatocellular carcinoma (HCC) confirmed by imaging, pathology or cytology.
- No macrovascular tumor thrombus or extrahepatic metastasis detected on imaging examinations.
- Single intrahepatic tumor >5 cm in diameter, or 2-3 intrahepatic tumors with no restriction on tumor diameter (corresponding to CNLC stage Ib-IIa of primary liver cancer in China).
Key exclusion criteria (17 listed)
- Histologically or cytologically confirmed tumors containing components of fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, or other mixed subtypes.
- History of hepatic encephalopathy or prior liver transplantation.
- Currently participating in an interventional clinical trial, or received any investigational medicinal product or investigational device within 4 weeks prior to the first study drug administration.
- Prior receipt of any of the following therapies: anti-PD-1, anti-PD-L1, anti-PD-L2 agents, or agents targeting other T-cell co-stimulatory or co-inhibitory receptors (including but not limited to CTLA-4, OX-40, CD137).
- Received systemic therapy with Chinese patent medicines with anti-tumor indications or immunomodulatory agents (including thymopeptides, interferons, interleukins; excluding local intrapleural administration for controlling pleural effusion) within 2 weeks prior to the first study drug administration.
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 |
|---|---|---|
| IBI310+ sintilimab + bevacizumabsystemic therapy | Drug | IBI310+ sintilimab + bevacizumab |
| IBI310+ sintilimabsystemic therapy | Drug | IBI310+ sintilimab |
| sintilimab + bevacizumabsystemic therapy | Drug | sintilimab + bevacizumab |
Primary outcome
Average depth of pathological response
Time frame: 6 months
Pathological response depth is defined as the proportion of non-viable tumors in surgical specimens to the total sample after neoadjuvant therapy. The average pathological response depth is defined as the average value of the pathological response depth.
2 secondary outcomes
1y-RFS rate
Time frame: 12 months
1y-EFS rate
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IBI310+ sintilimab + bevacizumab, IBI310+ sintilimab and sintilimab + bevacizumab in people with Resectable Hepatocellular Carcinoma, run by Shanghai Zhongshan Hospital.
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 11 inclusion and 17 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: opening soon, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huichuan Sun, MD, PHD (021-64041990, sun.huichuan@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average depth of pathological response (time frame: 6 months). 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 20 Jul 2026.