About this trial
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
Qualifiers
Voluntarily signs the informed consent form, and has good compliance.
Male or female, aged 18 years or older.
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.
Neoantigen load requirement: at least 10 predicted neoantigen epitopes.
Disqualifiers
ECOG performance status of 0 or 1.
Life expectancy of at least 6 months.
Women of childbearing potential include premenopausal women and those within 2 years post-menopause.
A negative serum pregnancy test is required within 7 days before the first dose of the investigational product.
Trial design
Treatments tested in this trial
- Neoantigen Personalized Cancer Vaccine
Treatment groups
Sponsors and collaborators
Ruijin Hospital
Lead sponsor
deepGeneAI
Collaborator
Bio-X Institutes, Shanghai Jiao Tong University
Collaborator