drugset / Trial / NCT06956716
Personalized Tumor Neoantigen mRNA Therapy for Advanced Intrahepatic Cholangiocarcinoma
Phase 1/2
Recruiting
30 enrolled
Zhejiang University
Hangzhou Neoantigen Therapeutics Co., Ltd. · collab
NaSingle-groupOpen-labelTreatment
Summary
The main purpose of this study is to evaluate the feasibility and safety of personalized tumor neoantigen mRNA therapy iNeo-Vac-R01 combined with PD-1 monoclonal antibody and standard chemotherapy regimen for the treatment of patients with advanced intrahepatic cholangiocarcinoma.
Timeline
- Start
- 2025-04-09
- Primary completion
- 2027-04-01
- Completion
- 2028-04-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 25 mg/m2 | Intravenous |
| Subject | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Subject | Sintilimab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | iNeo-Vac-R01 | Messenger RNA (mRNA) | 100 ug | Other |