drugset / Trial / NCT07683221
SBRT Followed by Ipilimumab N01, Sintilimab, Nab-Paclitaxel and Gemcitabine for Locally Advanced Pancreatic Cancer
NaSingle-groupOpen-labelTreatment
Summary
This is a Phase II, prospective, single-arm exploratory clinical trial designed to evaluate the efficacy and safety of stereotactic body radiotherapy followed by ipilimumab N01 plus sintilimab in combination with nab-paclitaxel and gemcitabine in patients with locally advanced pancreatic cancer. Eligible patients will receive SBRT followed by sequential systemic therapy. The primary endpoint is progression-free survival, and secondary endpoints include overall survival, disease control rate, duration of response, objective response rate, and safety.
Timeline
- Start
- 2026-07-15
- Primary completion
- 2029-07-15
- Completion
- 2029-07-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gemcitabine | Small molecule | 1000 mg/m2 | — |
| Subject | Ipilimumab N01 | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | Paclitaxel | Small molecule | 125 mg/m2 | — |
| Subject | Sintilimab | Monoclonal antibody | 200 mg | Intravenous |