OncoMatch/Clinical Trials/NCT07067385
Personalized mRNA Cancer Vaccine for Gastrointestinal Solid Tumor Treatment
Is NCT07067385 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Neoantigen Personalized Cancer Vaccine for personalized neoantigen vaccine in combination with anti-pd-1 inhibitors in standard therapy-failed and adjuvant therapy.
Treatment: Neoantigen Personalized Cancer Vaccine — Evaluating the efficacy and safety of Neoantigen Personalized Cancer Vaccine deepGeneAI-001 in combination with Sintilimab in the treatment of Gastrointestinal Solid Tumors
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Gastric Cancer
Hepatocellular Carcinoma
Pancreatic Cancer
Cholangiocarcinoma
Esophageal Carcinoma
Disease stage
Required: Stage IV
recurrent or metastatic gastrointestinal solid tumors not amenable to surgical or local curative treatment, with at least one measurable lesion as defined by RECIST v1.1
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard antitumor therapy
disease progression following standard antitumor therapy or be unable or unwilling to receive standard treatment
Cannot have received: cell therapy (TCR-T, CAR-T, TILs)
Prior treatment with cell therapies (e.g., TCR-T, CAR-T, TILs)
Cannot have received: neoantigen-based cancer vaccine
Prior treatment with ... neoantigen-based cancer vaccines
Cannot have received: immune checkpoint inhibitor
Prior treatment with immune checkpoint inhibitors (e.g., PD-1, PD-L1)
Cannot have received: immune-stimulating agent (thymosin, interferon, interleukin-2)
Receipt of immune-stimulating agents (e.g., thymosin, interferon, interleukin-2) within 6 weeks before study treatment
Lab requirements
Blood counts
ANC ≥ 1.5 × 10⁹/L, WBC ≥ 3 × 10⁹/L, PLT ≥ 100 × 10⁹/L, HGB ≥ 90 g/L; no blood/platelet transfusions, G-CSF, or EPO within one week before screening
Kidney function
Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula)
Liver function
AST and ALT ≤ 3 × ULN (≤ 5 × ULN for patients with liver cancer or liver metastases); TBIL ≤ 1.5 × ULN (patients with Gilbert's syndrome: TBIL < 3 × ULN)
Cardiac function
No severe dysfunction of the heart; see exclusion for specific cardiac/cerebrovascular diseases
Adequate organ and hematologic function, with no severe dysfunction of the heart, lungs, liver, kidneys, or immune system, based on the following laboratory values: ... (see full criteria for details)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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