drugset / Trial / NCT04890522
An Open-label, Multicentre, Phase II/III RCT of PFLL Versus GP Combined With JS001 as the First-line Therapy for mNPC
Phase 2/3
Not yet recruiting
622 enrolled
Sun Yat-sen University
Shanghai Junshi Bioscience Co., Ltd. · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The treatment of distant metastasis is a key challenge for nasopharyngeal carcinoma because of poor outcomes, among which, chemotherapy is the cornerstone. However, many studies reported the use of different chemotherapy regimens to prolong the survival of metastatic nasopharyngeal carcinoma, while few of them focused on how to reduce the side effects of chemotherapy or improve the life quality of patients. Blocking the immune checkpoint is one of the effective strategies of tumor immunotherapy. Thus, we sought to find a proper chemotherapy regimen combined with PD-1 antibody JS001.
Timeline
- Start
- 2021-07-01
- Primary completion
- 2023-12-31
- Completion
- 2028-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 80 mg/m2 | Intravenous |
| Comparator | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Subject | Triprilimab | Monoclonal antibody | 240 mg | Intravenous |
| Subject | fluorouracil | Small molecule | 200 mg/m2 | Intravenous |