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)

July 15, 2026 updated by: Shanghai Zhongshan Hospital
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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Written informed consent shall be obtained prior to any trial-related procedures.
  2. Male or female patients aged ≥18 years and ≤75 years.
  3. Initial resectable hepatocellular carcinoma (HCC) confirmed by imaging, pathology or cytology.
  4. No macrovascular tumor thrombus or extrahepatic metastasis detected on imaging examinations.
  5. 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).
  6. The maximum tumor diameter < 8 cm.
  7. Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.
  8. Child-Pugh Class A liver function.
  9. 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.
  10. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
  11. Adequate organ function.

Exclusion Criteria:

  1. Histologically or cytologically confirmed tumors containing components of fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, or other mixed subtypes.
  2. History of hepatic encephalopathy or prior liver transplantation.
  3. 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.
  4. 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).
  5. 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.
  6. 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.

  7. 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.

  8. Known history of allogeneic solid organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation.
  9. Known hypersensitivity to any study drug used in this trial.
  10. Have not fully recovered from toxicities and/or complications induced by any prior intervention before study treatment initiation.
  11. Known history of human immunodeficiency virus (HIV) infection.
  12. Untreated active hepatitis B virus (HBV) infection.
  13. Subjects with active hepatitis C virus (HCV) infection.
  14. Received any live vaccine within 30 days prior to the first study drug administration (Day 1 of Cycle 1).
  15. Pregnant or lactating women.
  16. Presence of any severe or uncontrolled systemic disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: IBI310+ sintilimab + bevacizumab
Drug: IBI310+ sintilimab + bevacizumab
systemic therapy
Experimental: IBI310+ sintilimab
Drug: IBI310+ sintilimab
systemic therapy
Experimental: sintilimab + bevacizumab
Drug: sintilimab + bevacizumab
systemic therapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
1y-RFS rate
Time Frame: 12 months
The proportion of patients without disease recurrence or death within 1 year following the second randomization
12 months
1y-EFS rate
Time Frame: 12 months
The proportion of patients without disease progression precluding surgical resection, post-operative disease recurrence, or death within 1 year after the first randomization
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Zhongshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 20, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 15, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Prophet-IBI310

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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