Surufatinib in Combination With Iparomlimab and Tuvonralimab Injection and AG Chemotherapy for Neoadjuvant Therapy of HRPC or BRPC
Summary
This is a prospective, single-center, single-arm phase 2 study evaluating the efficacy and safety of neoadjuvant surufatinib plus iparomlimab and tuvonralimab injection and nab-paclitaxel/gemcitabine chemotherapy in patients with high-risk resectable or borderline resectable pancreatic cancer. Approximately 56 participants will be enrolled, including about 19 patients with high-risk resectable disease and 37 patients with borderline resectable disease. Participants will receive up to four 21-day cycles of neoadjuvant treatment. Participants considered eligible for surgery will undergo surgical resection approximately 4 weeks after neoadjuvant treatment. After surgery, adjuvant chemotherapy with either gemcitabine plus capecitabine or modified FOLFIRINOX will be selected by the investigators after multidisciplinary team review. The primary outcome is the 12-month event-free survival rate.
Timeline
- Start
- 2026-09-01
- Primary completion
- 2028-09-01
- Completion
- 2029-09-01
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 | Iparomlimab | Monoclonal antibody | 5 mg/kg | Intravenous |
| Subject | Irinotecan | Small molecule | 150 mg/m2 | — |
| Subject | Leucovorin | Small molecule | 400 mg/m2 | — |
| Subject | Nab-paclitaxel | Small molecule | 125 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | — |
| Subject | Surufatinib | Small molecule | 200 mg | Oral |
| Subject | Tuvonralimab | Monoclonal antibody | 5 mg/kg | Intravenous |
| Subject | fluorouracil | Small molecule | 2400 mg/m2 | — |