drugset / Trial / NCT05241132
Tislelizumab Combined With Chemotherapy in the Treatment of Bone Metastases of Unknown Primary
NaSingle-groupOpen-labelTreatment
Summary
Through scientific and rigorous design, implementation, follow-up and statistics, the sponsor aims to explore the clinical efficacy and safety of Tislelizumab combined with chemotherapy (platinum + paclitaxel) in the treatment of patients with bone metastases cancer with unknown primary, and provide a better treatment plan for these patients. 1. Primary outcome: Objective response rate (ORR) 2. Secondary outcomes: disease control rate (DCR), duration of remission (DOR), progression-free disease (PFS), overall survival (OS), median PFS, median OS, stratification based on clinical features and PD-L1 expression, adverse reactions (AEs), and quality of life.
Timeline
- Start
- 2021-11-12
- Primary completion
- 2023-06-30
- Completion
- 2024-10-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tislelizumab | Monoclonal antibody | 200 mg | Intravenous |
| Background | Cisplatin | Other / unclassified | 100 mg/m2 | Intravenous |
| Background | Paclitaxel | Small molecule | 175 mg/m2 | Intravenous |