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Efficacy and Safety of Second-line Therapy by Nal-IRI/5-FU/LV Chemotherapy Combined With PD-L1 Inhibitor and Multi-target Anti-angiogenic Small Molecule±SBRT in Metastatic Pancreatic Cancer Patients: a Prospective, Multicentre, Single-arm, Multi-cohort Study
This study is a single-arm, multi-center, multi-cohort, prospective clinical study initiated by the investigator. The indication of this study is: patients with advanced metastatic pancreatic cancer who have progressed after first-line chemotherapy. Eligible patients will be assigned to liposomal irinotecan (nal-IRI) plus 5-fluorouracil (5-FU)/leucovorin (LV) (nal-IRI/5-FU/LV) combined with benmelstobart and anlotinib ± SBRT. The total sample size for this study is expected to be 56 subjects.
Details
| Lead sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School |
|---|---|
| Phase | Phase 2 |
| Status | RECRUITING |
| Enrolment | 56 |
| Start date | 2024-03-01 |
| Completion | 2027-12 |
Conditions
- Advanced Metastatic Pancreatic Cancer
Interventions
- nal-IRI,5-fu,LV, benmelstobart, anlotinib
Primary outcomes
- Objective effective rate (ORR) — 28 days per cycle, with ≤6 cycles of treatment expected per patient
The overall response rate, including complete response (CR) + partial response (PR), refers to the proportion of patients whose tumor shrinks to a certain amount and remains for a certain period of time.
Countries
China