drugset / Trial / NCT05433597
A Two-blinded, Multicentre, Phase II/III RCT of Concurrent Chemo-radiotherapy Combined or Not Combined With TNF as the Therapy for LA-NPC
Phase 2/3
Not yet recruiting
172 enrolled
Sun Yat-sen University
Shanghai Weike Bioscience Co., Ltd. · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Based on the application prospect of rmh-TNF combined with chemotherapy in the treatment of solid tumors. In this study, cisplatin combined with low dose 5-FU was proposed to enhance the immune function of 5-FU. Tianenfu is a novel recombinant modified human tumor necrosis with high activity and low toxicity. The fact that RMH-TNF has the potential of better in vivo efficacy and clinical antitumor effect. Therefore, the study was designed to investigate the treatment of concurrent chemoradiotherapy combined with TNF versus concurrent chemoradiotherapy combined with placebo for the efficacy and safety of advanced nasopharyngeal carcinoma.
Timeline
- Start
- 2022-07-01
- Primary completion
- 2024-07-01
- Completion
- 2029-07-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Tianenfu | Unknown | 1e+06 iu | Intramuscular |
| Comparator | Tianenfu | Unknown | 1.5e+06 iu | Intramuscular |
| Comparator | Cisplatin | Other / unclassified | 80 mg/m2 | — |
| Comparator | fluorouracil | Small molecule | 200 mg/m2 | Intravenous |