drugset / Trial / NCT06888674
Personalized Tumor Neoantigen MRNA Therapy Adjuvant Treatment for Postoperative Pancreatic Cancer.
Phase 1/2
Not yet recruiting
60 enrolled
Zhejiang University
Hangzhou Neoantigen Therapeutics Co., Ltd. · collab
Non-randomizedParallel-groupOpen-labelPrevention
Summary
This study is a single-center, open-label clinical study to evaluate the feasibility and safety of personalized tumor neoantigen mRNA therapy (iNeo-Vac-R01) in combination with PD-1 antibody and standard chemotherapy regimen as adjuvant treatment for postoperative resectable pancreatic cancer.
Timeline
- Start
- 2025-04-01
- Primary completion
- 2027-04-01
- Completion
- 2029-04-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 1650 mg/m2 | Oral |
| Subject | Capecitabine | Small molecule | 2000 mg/m2 | Oral |
| Subject | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Subject | Sintilimab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | iNeo-Vac-R01 | Messenger RNA (mRNA) | 100 ug | Subcutaneous |