A Clinical Study on the Safety, Tolerability and Efficacy of Neoantigen-based Personalized mRNA Therapy iNeo-Vac-R01 Plus PD-1 Inhibitor in Adjuvant Treatment of Liver Cancer Post Radical Resection

NCT07495215 | Recruiting Phase 1 DMC

• 1 other identifier: 2025-2715-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

iNeo-Vac-R01, a personalized neoantigen-based mRNA therapeutic technology for tumors, is a customized neoantigen mRNA injectable formulation developed by collecting patients' tumor tissues and peripheral blood, screening appropriate neoantigens via high-throughput sequencing, and encapsulating these neoantigens into mRNA liposomes. It can precisely induce the proliferation of patient-specific T cells to eliminate tumor cells. This tumor therapeutic approach that harnesses the body's own immune system features high efficacy and low toxicity, with milder treatment responses and no severe adverse reactions for patients. This study aims to provide a novel personalized therapeutic strategy for the adjuvant treatment of post-operative liver cancer patients, with the research objectives of prolonging their disease-free survival (DFS) and overall survival (OS) following surgery.

Conditions

Hepatocellular Carcinoma (HCC)

Outcome Measures

Primary Outcomes (1)

• safety and tolerability dose

  According to the Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0), the number of subjects with adverse events and/or dose-limiting toxicities will be counted as an indicator to evaluate the safety and tolerability of iNeo-Vac-R01 Injection. The safety data visit window will be 21 days after the last treatment.

  210 days

Secondary Outcomes (1)

• Primary efficacy endpoints，include disease-free survival (DFS) and overall survival (OS)

  3 years

Study Arms (1)

Participant Group

EXPERIMENTAL

Biological: iNeo-Vac-R01

Interventions

iNeo-Vac-R01 BIOLOGICAL

iNeo-Vac-R01, a personalized neoantigen-based mRNA therapeutic technology for tumors, is a custom-made neoantigen mRNA injectable formulation produced by collecting patients' tumor tissues and peripheral blood, screening eligible neoantigens via high-throughput sequencing, and encapsulating these neoantigens into mRNA liposomes. It can precisely induce the proliferation of patient-specific T cells, thereby eliminating tumor cells.

Participant Group

Eligibility Criteria

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

You may qualify if:

• Aged 18 to 75 years old (at the time of signing the informed consent form).
• Patients with histopathologically or cytologically confirmed hepatocellular carcinoma (HCC) eligible for radical resection; no tumor thrombus in the portal vein, hepatic vein or bile duct on pre-operative imaging; for multinodular patients, the number of tumor nodules ≤ 3 and no extrahepatic metastasis; clear margins of all tumor nodules and negative surgical margins after radical resection.
• High risk of postoperative recurrence, where high risk is defined as a single tumor lesion with microvascular invasion, or 2-3 tumor lesions; intermediate risk is defined as a single tumor lesion with a diameter \> 5 cm and no microvascular invasion.

You may not qualify if:

• Expected survival time of at least 6 months.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
• Sufficient tumor tissue samples can be obtained for genetic analysis: for puncture samples, at least 2 core biopsy tissues with tumor purity ≥ 50%; for surgical samples, a soybean-sized tissue sample.
• Echocardiography assessment: left ventricular ejection fraction (LVEF) ≥ 50%.
• Hematological parameters meeting the following requirements:
• ① Routine blood test criteria
• Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L
• Hemoglobin (Hb) ≥ 90 g/L (no red blood cell transfusion within 7 days before the first administration of the mRNA injectable formulation)
• Platelet count ≥ 80 × 10⁹/L ② Biochemical parameter criteria
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• Total bilirubin ≤ 1.5 × upper limit of normal (ULN)
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN
• Serum albumin ≥ 28 g/L
• Serum creatinine ≤ 1.5 × ULN, or estimated glomerular filtration rate (eGFR) ≥ 50 mL/min (per Cockcroft-Gault formula)
• Coagulation function criteria: Prothrombin time (PT), activated partial thromboplastin time (APTT), international normalized ratio (INR) ≤ 1.5 × ULN (in patients not receiving anticoagulant therapy)

Sponsors & Collaborators

• Yinghua Xu: lead

Study Sites (1)

Department of General Surgery, Institute of Minimally Invasive Surgery, Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, 310016, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

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

Central Study Contacts

Yinghua Xu

CONTACT

+86 13666627003; xyh7003@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician，Director，Principal Investigator

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 27, 2026
• Study Start: September 11, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 27, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)