drugset / Trial / NCT05218629
Anlotinib Plus PD-1 Inhibitor as 2nd-line Threapy in Patients With Metastatic Pancreatic Cancer
NaSingle-groupOpen-labelTreatment
Summary
This research study is a Phase 2 clinical trial. It will test the efficiency and safety of an investigational drug of Anlotinib (a small molecular anti-VEGF TKI) with PD-1 inhibitor in second-line therapy with the goal of determining the OS of metastatic pancreatic adenocarcinoma. Subjects must have a stage 4 untreated metastatic pancreatic ductal cancer failed to first-line chemotherapy and meet all inclusion/exclusion criteria. Treatment consists of treatment with anlotinib 8-12 mg oral, day 1-14, and PD-1 inhibitor 200 mg iv, every 21 days each cycle. Treatment will be administered until untolerable toxicities or progression or subject death, or either the subject or sponsor discontinues the study.
Timeline
- Start
- 2022-01-01
- Primary completion
- 2024-12-31
- Completion
- 2025-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Catequentinib | Small molecule | 8 mg | Oral |
| Subject | Catequentinib | Small molecule | 12 mg | Oral |
| Subject | Catequentinib | Small molecule | 14 mg | Oral |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |
Indications
No indication recorded.