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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.

Phase 1RecruitingSir Run Run Shaw HospitalNCT06026774Data as of May 2026

Treatment: iNeo-Vac-R01 in combination with standard adjuvant therapyThe 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.

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Extracted 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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