Personalized mRNA Cancer Vaccine for Gastrointestinal Solid Tumor Treatment (PCV-GSTT)

Personalized mRNA Cancer Vaccine for Gastrointestinal Solid Tumor Treatment (PCV-GSTT)

Gastrointestinal Stromal Tumor

Recruiting

1

Start Date 07/01/2025

Age of Trial (yrs) .9

Adjuvant First-line

Personalized vaccine + PD-1 inhibitor

Specifically GIST and only GIST

JZ202401

Ruijin Hospital

Hao Li, MD, PhD 86-15000660260 lh11001@rjh.com.cn

Intravenous

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
Detailed Description
This is a single-center, open, single-arm exploratory clinical study to evaluate the efficacy and safety of Neoantigen Personalized Cancer Vaccine deepGeneAI-001 in combination with Sintilimab in the treatment of Gastrointestinal Solid Tumors, and to provide more clinical treatment options for gastrointestinal cancer patients.
Official Title
Exploratory Clinical Study of Neoantigen Tumor Vaccine Therapy for Gastrointestinal Solid Tumors

Eligibility

Partial Inclusion Criteria (See NCT listing at clinicaltrials.gov for full eligibility criteria)

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.
Neoantigen load requirement: at least 10 predicted neoantigen epitopes.
The subject must have a tumor lesion suitable for repeated sampling for sequencing and immune testing. Fresh or archived tumor tissue is required, preferably from surgical or core needle biopsy (CNB) samples, including both tumor and 2-3 soybean-sized peritumoral tissues. Paraffin blocks or at least 10-20 unstained tumor tissue sections (4-6 μm thick) with tumor content >20% are acceptable. If the subject cannot provide suitable samples but meets other inclusion/exclusion criteria, the investigator may still consider enrollment.


Partial Exclusion Criteria

Receipt of the following therapies or interventions within 28 days before the first dose of study drug:

Participation in an interventional clinical study;
Major surgery or traumatic injury, or expected to undergo major surgery during the study (minor procedures such as core needle biopsy or placement of a vascular access device within 7 days before the first dose are permitted);
Vaccination with a live attenuated vaccine, or planned vaccination during the study or within 5 months after the last dose of study treatment;
Systemic antitumor therapy (including chemotherapy, small molecule targeted therapy, antibody therapy, cellular immunotherapy, hormonal therapy), or local antitumor therapy (e.g., radiotherapy). Palliative radiotherapy for bone metastases completed >2 weeks before baseline tumor assessment is allowed. Also includes prior treatment with systemic immune-stimulating agents (e.g., interferons or interleukin-2).