drugset / Trial / NCT06662006
Nal-IRI/5-FU/LV Chemotherapy Combined With PD-L1 Inhibitor and Multi-target Anti-angiogenic Small Molecule±SBRT as Second-line Therapy in Metastatic Pancreatic Cancer Patients
Phase 2
Recruiting
56 enrolled
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
NaSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2024-03-01
- Primary completion
- 2027-12
- Completion
- 2027-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Benmelstobart | Monoclonal antibody | 1200 mg | Intravenous |
| Subject | Catequentinib | Small molecule | 12 mg | Oral |
| Subject | Irinotecan Sucrosofate | Other / unclassified | 50 mg/m2 | Intravenous |
| Subject | Leucovorin | Small molecule | 400 mg/m2 | Intravenous |
| Subject | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |