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RecruitingPhase 1NCT07067385

Personalized mRNA Cancer Vaccine for Gastrointestinal Solid Tumor Treatment

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Trial Parameters

ConditionPersonalized Neoantigen Vaccine in Combination With Anti-PD-1 Inhibitors in Standard Therapy-Failed and Adjuvant Therapy
SponsorRuijin Hospital
Study TypeINTERVENTIONAL
PhasePhase 1
Enrollment40
SexALL
Min Age18 Years
Max AgeN/A
Start Date2025-07-01
Completion2027-12-31
Interventions
Neoantigen Personalized Cancer Vaccine

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Brief Summary

Evaluating the efficacy and safety of Neoantigen Personalized Cancer Vaccine deepGeneAI-001 in combination with Sintilimab in the treatment of Gastrointestinal Solid Tumors

Eligibility Criteria

Inclusion Criteria: 1. Voluntarily signs the informed consent form, and has good compliance. 2. Male or female, aged 18 years or older. 3. Patients with advanced gastrointestinal tumors: histologically and/or cytologically confirmed 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. Eligible patients must have experienced disease progression following standard antitumor therapy or be unable or unwilling to receive standard treatment. Patients with resectable gastrointestinal solid tumors for adjuvant treatment: tumors must be confirmed as completely resected (R0 or R1) by postoperative histopathology, with no prior neoadjuvant therapy, and assessed as fully resectable by imaging. 4. Neoantigen load requirement: at least 10 predicted neoantigen epitopes. 5. The subject must have a tumor lesion suitable for repeated sampling for sequencing and immune testing. Fresh or a

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