OncoMatch/Clinical Trials/NCT06019702
Clinical Study of Personalized mRNA Vaccine Encoding Neoantigen Alone in Subjects With Advanced Digestive System Neoplasms
Is NCT06019702 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies iNeo-Vac-R01 for digestive system neoplasms.
Treatment: iNeo-Vac-R01 — The purpose of this study is to assess the safety, feasibility, and efficacy of personalized mRNA vaccine iNeo-Vac-R01 alone in subjects with advanced digestive system neoplasms.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Gastric Cancer
Hepatocellular Carcinoma
Pancreatic Cancer
Cholangiocarcinoma
Esophageal Carcinoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: standard treatment
Subjects must have tumor progression after standard treatment or are intolerant or are unwilling to receive standard treatment.
Cannot have received: bone marrow transplantation
Subjects who prepare to undergo or have previously received 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
Cannot have received: other anti-tumor treatments
Subjects who receive other anti-tumor treatments within 2 weeks prior to the first dose of iNeo-Vac-R01, including surgical treatment, chemotherapy, radiation therapy, targeted therapy, endocrine therapy, immunotherapy, biological therapy, interventional therapy, or other clinical trial related treatments.
Lab requirements
Blood counts
absolute neutrophil count (ANC) >= 1.5 × 10^9/L, platelet count (PLT) >= 80 × 10^9/L, hemoglobin (Hb) >= 90 g/L
Kidney function
serum creatinine <= 1.5 × BUN, Glomerular filtration rate >= 50mL/min
Liver function
serum total bilirubin (TBIL) <= 1.5 × ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5 × ULN (if there is liver metastasis, TBIL <= 3 × ULN, AST, ALT <= 5 × ULN are allowed), serum albumin >= 28g/L
Cardiac function
left ventricular ejection fraction (LVEF) >= 50%
The organ function level must meet the following requirements: absolute neutrophil count (ANC) >= 1.5 × 10^9/L, platelet count (PLT) >= 80 × 10^9/L, hemoglobin (Hb) >= 90 g/L; serum total bilirubin (TBIL) <= 1.5 × ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5 × ULN (if there is liver metastasis, TBIL <= 3 × ULN, AST, ALT <= 5 × ULN are allowed), serum albumin >= 28g/L, serum creatinine <= 1.5 × BUN, Glomerular filtration rate >= 50mL/min, prothrombin time (PT) and activated partial thromboplastin time (APTT) and international standardized ratio (INR) <= 1.5 × ULN (without anticoagulant therapy). Echocardiographic evaluation: left ventricular ejection fraction (LVEF) >= 50%.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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