OncoMatch/Clinical Trials/NCT07495215
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
Is NCT07495215 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies iNeo-Vac-R01 for hepatocellular carcinoma (hcc).
Treatment: iNeo-Vac-R01 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: postoperative adjuvant therapy — postoperative
Able to complete at least 4 cycles of the standard postoperative adjuvant therapy regimen in accordance with clinical guidelines
Cannot have received: bone marrow transplantation
Planned or prior history of bone marrow transplantation
Cannot have received: allogeneic organ transplantation
allogeneic organ transplantation
Cannot have received: allogeneic hematopoietic stem cell transplantation
allogeneic hematopoietic stem cell transplantation
Lab requirements
Blood counts
ANC ≥ 1.5 × 10⁹/L; Hemoglobin ≥ 90 g/L (no RBC transfusion within 7 days before first administration); Platelet count ≥ 80 × 10⁹/L
Kidney function
Serum creatinine ≤ 1.5 × ULN, or eGFR ≥ 50 mL/min (per Cockcroft-Gault formula)
Liver function
Total bilirubin ≤ 1.5 × ULN; AST and ALT ≤ 2.5 × ULN; serum albumin ≥ 28 g/L
Cardiac function
LVEF ≥ 50%; PT, APTT, INR ≤ 1.5 × ULN (in patients not receiving anticoagulant therapy)
Echocardiography assessment: LVEF ≥ 50%. Routine blood test criteria: ANC ≥ 1.5 × 10⁹/L, Hemoglobin ≥ 90 g/L (no red blood cell transfusion within 7 days before the first administration), Platelet count ≥ 80 × 10⁹/L. Biochemical parameter criteria: Total bilirubin ≤ 1.5 × ULN, AST and ALT ≤ 2.5 × ULN, serum albumin ≥ 28 g/L, serum creatinine ≤ 1.5 × ULN or eGFR ≥ 50 mL/min. Coagulation function criteria: PT, APTT, INR ≤ 1.5 × ULN (in patients not receiving anticoagulant therapy).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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