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)

NCT07714317 | Not Yet Recruiting Phase 1

• 1 other identifier: Prophet-IBI310
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Resectable Hepatocellular Carcinoma

Keywords

peri-operative treatment; hepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (2)

• 1y-RFS rate

  12 months

• 1y-EFS rate

  12 months

Study Arms (3)

IBI310+ sintilimab + bevacizumab

EXPERIMENTAL

Drug: IBI310+ sintilimab + bevacizumab

IBI310+ sintilimab

EXPERIMENTAL

Drug: IBI310+ sintilimab

sintilimab + bevacizumab

EXPERIMENTAL

Drug: sintilimab + bevacizumab

Interventions

IBI310+ sintilimab DRUG

systemic therapy

IBI310+ sintilimab

sintilimab + bevacizumab DRUG

systemic therapy

sintilimab + bevacizumab

IBI310+ sintilimab + bevacizumab DRUG

systemic therapy

IBI310+ sintilimab + bevacizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Bevacizumab; sintilimab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Huichuan Sun, MD, PHD

CONTACT

021-64041990; sun.huichuan@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 20, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): May 31, 2030
• Last Updated: July 20, 2026

Record last verified: 2026-07