OncoMatch/Clinical Trials/NCT06026774
Clinical Study of Personalized mRNA Vaccine Encoding Neoantigen in Subjects With Resected Digestive System Neoplasms
Is NCT06026774 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies iNeo-Vac-R01 in combination with standard adjuvant therapy for digestive system neoplasms.
Treatment: iNeo-Vac-R01 in combination with standard adjuvant therapy — The purpose of this study is to assess the safety, feasibility, and efficacy of personalized mRNA vaccine iNeo-Vac-R01 with standard adjuvant therapy in subjects with surgically resected 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 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard adjuvant therapy — post-surgery
Subjects must be able to receive at least 4 cycles of standard adjuvant therapy according to CSCO clinical guidelines after surgery
Cannot have received: anti-tumor treatment
Exception: except stage I prostate cancer, cervical cancer in situ, breast cancer in situ, papillary thyroid cancer and non-melanoma skin cancer that have been treated
Subjects with cancer requiring anti-tumor treatment within the 5 years prior to enrollment in the study (except stage I prostate cancer, cervical cancer in situ, breast cancer in situ, papillary thyroid cancer and non-melanoma skin cancer that have been treated)
Cannot have received: major surgery
Subjects who received major surgery, or had obvious traumatic injury or long-term untreated wounds or fractures within 2 weeks prior to the first dose of iNeo-Vac-R01
Cannot have received: bone marrow transplantation, allogeneic organ transplantation, or allogeneic hematopoietic stem cell transplantation
Subjects who prepare to undergo or have previously received bone marrow transplantation, allogeneic organ transplantation, or allogeneic hematopoietic stem cell transplantation
Cannot have received: 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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