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

NCT05433597

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

EvaluationDrugModalityDoseRoute
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