Phase 1 Study of Personalized Neoantigen mRNA Vaccine with Sintilimab for Treatment of Gastrointestinal Solid Tumors

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a personalized cancer vaccine called deepGeneAI-001 combined with the drug Sintilimab for treating gastrointestinal solid tumors. This open, single-arm exploratory clinical study aims to offer new treatment options for patients with these types of cancers. The study is sponsored by Ruijin Hospital and focuses on patients with advanced or resectable gastrointestinal tumors, including those who have not responded to standard therapies or require adjuvant treatment after surgery. Participants receive the neoantigen personalized cancer vaccine alongside Sintilimab, with some also receiving chemotherapy depending on their treatment cohort. The study includes two groups Cohort 1 receives the vaccine with Sintilimab as salvage therapy, while Cohort 2 receives the vaccine, Sintilimab, and chemotherapy as adjuvant therapy. Treatments are tailored based on tumor characteristics and patients undergo repeated tumor sampling for sequencing and immune testing. During the study, participants will be monitored for adverse events for up to 2.5 years using standard grading criteria. Researchers will measure immune responses by analyzing specific T lymphocytes in blood samples. Additional outcomes include tumor response rates, disease control, survival rates, and recurrence-free survival depending on the cohort. Participants will provide blood and tissue samples and be assessed regularly to track safety, immune activity, and clinical outcomes throughout the study period.

Personalized mRNA Cancer Vaccine for Gastrointestinal Solid Tumor Treatment