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 (Jun 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
Treatments studied
Other
Cancer type
Colorectal Cancer
Gastric Cancer
Hepatocellular Carcinoma
Pancreatic Cancer
Cholangiocarcinoma
Esophageal Carcinoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
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.
Frequently asked questions
Is NCT06019702 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior bone marrow transplantation, allogeneic organ transplantation, allogeneic hematopoietic stem cell transplantation disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages