drugset / Trial / NCT05380271
Efficacy and Safety of DEB-BACE With Sequential Arotinib and Tirelizumab in the Treatment of Advanced NSCLC
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a prospective, open-labelled study to evaluate the efficacy and safety of arterial infusion chemotherapy combined with drug loaded microspheres embolization with sequential arotinib and tirelizumab in the treatment of advanced NSCLC. The progression-free-survival (PFS) will be evaluated as the primary endpoints.
Timeline
- Start
- 2022-07-01
- Primary completion
- 2022-12-01
- Completion
- 2025-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Arotinib | Unknown | 8 mg | Oral |
| Subject | Arotinib | Unknown | 12 mg | Oral |
| Subject | Tirelizumab | Monoclonal antibody | 200 mg | Intravenous |
| Comparator | Letitrexed | Unknown | 3 mg/m2 | Other |
| Comparator | Nedaplatin | Small molecule | 40 mg/m2 | Other |
| Background | THP | Unknown | 20 mg/m2 | Other |
| Comparator | THP | Unknown | 20 mg/m2 | Other |
| Background | THP | Unknown | 30 mg/m2 | Other |
| Comparator | THP | Unknown | 30 mg/m2 | Other |
| Background | THP | Unknown | 40 mg/m2 | Other |
| Comparator | THP | Unknown | 40 mg/m2 | Other |
| Background | THP | Unknown | 600 mg/m2 | Other |
| Comparator | THP | Unknown | 600 mg/m2 | Other |