Clinical trial · Interventional
Clinical Study of mRNA Vaccine in Patients With Advanced Malignant Solid Tumors
Clinical Study on the Treatment of Advanced Malignant Solid Tumors With the Combination of mRNA
NCT05949775CI-TRIAL-00068065unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is an open, single arm, dose increasing study to evaluate the safety and efficacy of the combination of mRNA personalized tumor vaccine encoding neoantigen (hereinafter referred to as tumor vaccine) and Sintilimab injection (hereinafter referred to as Sintilimab) in the treatment of advanced malignant solid tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Malignant Solid Tumors | Malignant Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neoantigen mRNA Personalised Cancer vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- single arm
- description
- Neoantigen mRNA Personalised Cancer in combination with Stintilimab Injection. Participants will receive a total of 9 cycles of PCV every 21 days
- interventionNames
- Biological: Neoantigen mRNA Personalised Cancer vaccine
Primary outcomes (1)
- measure
- progression-free survival (PFS)
- timeFrame
- Time Frame: from enrolling to patients disease progression，assessed up to 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Are ≥18 years old, without limitation of sex at time of consent. * Patients with malignant solid tumors confirmed by histopathology or cytology and having at least one measurable lesion. * Fresh biopsy specimens can be provided for vaccine preparation. * Patients with malignant solid tumors who develop secondary drug resistance after receiving PD-1/PD-L1 drug therapy, including but not limited to gastric cancer, esophageal cancer, and other gastrointestinal tumors of MSI-H Exclusion Criteria: * It is known that it is allergic to any tumor vaccine and Sintilimab preparations; Or have experienced severe allergic reactions to other monoclonal antibodies in the past; * The predicted number of new antigens is less than 10; * Those who are pregnant or breastfeeding; * Those with an expected survival period of less than 3 months;
References
Publications (0)
Data not yet available
No reference posted for this study.