Last reviewed · How we verify
NCT06026800
Clinical Study of Personalized mRNA Vaccine Encoding Neoantigen in Combination With Standard First-line Treatment in Subjects With Advanced Digestive System Neoplasms
Recruiting now
Phase 1
Last updated 11 September 2023
What this trial tests
Phase 1 trial testing iNeo-Vac-R01 in Digestive System Neoplasms in 20 participants. Currently enrolling.
Timeline
8 September 2023
Primary endpoint
31 August 2027
31 August 2027
31 December 2027
Quick facts
| Lead sponsor | Sir Run Run Shaw Hospital |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 8 September 2023 |
| Primary completion | 31 August 2027 |
| Estimated completion | 31 December 2027 |
| Sites | 1 location across China |
Drugs / interventions tested
- iNeo-Vac-R01 — full drug profile →
Conditions studied
- Digestive System Neoplasms — all drugs for Digestive System Neoplasms →
Sponsor
Sir Run Run Shaw Hospital
Who can join
Adults 18 to 75, any sex, with Digestive System Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to assess the safety, feasibility, and efficacy of personalized mRNA vaccine iNeo-Vac-R01 in combination with first-line treatment in subjects with advanced digestive system neoplasms.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
The clinical impact of mRNA therapeutics in the treatment of cancers, infections, genetic disorders, and autoimmune diseases.
Deyhimfar R, Izady M, Shoghi M, Kazazi MH, et al · · 2024 · cited 17× · PMID 38486748 · DOI 10.1016/j.heliyon.2024.e26971 -
Leveraging mRNA technology for antigen based immuno-oncology therapies.
Floudas CS, Sarkizova S, Ceccarelli M, Zheng W. · · 2025 · cited 11× · PMID 39848687 · DOI 10.1136/jitc-2024-010569 -
The transformative potential of mRNA vaccines for glioblastoma and human cancer: technological advances and translation to clinical trials.
Tapescu I, Madsen PJ, Lowenstein PR, Castro MG, et al · · 2024 · cited 9× · PMID 39399167 · DOI 10.3389/fonc.2024.1454370 -
mRNA Vaccines: Current Applications and Future Directions.
Li J, Liu Y, Dai J, Yang L, et al · · 2025 · cited 5× · PMID 41179708 · DOI 10.1002/mco2.70434 -
Nanotechnology-based strategies for vaccine development: accelerating innovation and delivery.
Cheng M, Chai Y, Rong G, Xin C, et al · · 2025 · cited 5× · PMID 40313573 · DOI 10.12336/biomatertransl.2025.01.005 -
Unraveling the potential: mRNA therapeutics in oncology.
Gawalski K, Przybyszewska W, Hunia J, Gawalska A, et al · · 2025 · cited 4× · PMID 40881859 · DOI 10.3389/fonc.2025.1643444 -
Research progress on mechanisms of tumor immune microenvironment and gastrointestinal resistance to immunotherapy: mini review.
Zhang Z, Wu Y. · · 2025 · cited 4× · PMID 40787471 · DOI 10.3389/fimmu.2025.1641518 -
Therapeutic mRNA vaccine applications in oncology.
Elliott L, Foster T, Castillo P, Mendez-Gomez H, et al · · 2025 · cited 4× · PMID 40336197 · DOI 10.1016/j.ymthe.2025.04.044
Verify or expand the search:
- PubMed search for NCT06026800
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of iNeo-Vac-R01
Trials testing the same drug.
- NCT07495215 — A Clinical Study on the Safety, Tolerability and Efficacy of Neoantigen-based Personalized mRNA Therapy iNeo-Vac-R01 Plu · Phase 1, PHASE2 · recruiting
- NCT07368803 — Evaluation of the Safety, Tolerability and Efficacy of iNeo-Vac-R01, an Individualized mRNA Therapeutic Technology Based · Phase 1, PHASE2 · recruiting
- NCT06019702 — Clinical Study of Personalized mRNA Vaccine Encoding Neoantigen Alone in Subjects With Advanced Digestive System Neoplas · Phase 1 · recruiting
Other recruiting trials for Digestive System Neoplasms
Currently open trials in the same condition.
- NCT07222800 — Symbiotic-GI-03: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult · Phase 3 · recruiting
- NCT07404527 — Bioelectrical Impedance Analysis for Perioperative Fluid Evaluation in Colorectal Cancer Surgery · NA · recruiting
- NCT06026774 — Clinical Study of Personalized mRNA Vaccine Encoding Neoantigen in Subjects With Resected Digestive System Neoplasms · Phase 1 · recruiting
- NCT06019702 — Clinical Study of Personalized mRNA Vaccine Encoding Neoantigen Alone in Subjects With Advanced Digestive System Neoplas · Phase 1 · recruiting
- NCT05624099 — Camrelizumab Combined With Chemoradiotherapy in Advanced Esophageal Cancer. · Phase 2 · recruiting
Other Sir Run Run Shaw Hospital trials
Trials by the same sponsor.
- NCT07453940 — Left Atrial Appendage Closure With Versus Without Pulsed Field Ablation in Atrial Fibrillation Patients With Mild Sympto · NA · recruiting
- NCT07508943 — Decision-making and Optimization of Ventilatory Support for AECOPD Patients · not yet recruiting
- NCT07514533 — The Efficacy and Safety of Pucotenlimab (PD-1) Combined With Becotatugvedotin (EGFR-ADC) in Advanced Cholangiocarcinoma · Phase 2 · not yet recruiting
- NCT07350590 — Comparison Between Robotic and Laparoscopic Right Hemicolectomy · terminated
- NCT07457073 — AI-Powered Sound Analysis for COPD Screening · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT06026800 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sir Run Run Shaw Hospital
- Last refreshed: 11 September 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06026800.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing