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

A Two-blinded, Multicentre, Phase II/III RCT of Concurrent Chemo-radiotherapy Combined or Not Combined With TNF as the Therapy for Local-advancedNPC

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 172 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nasopharyngeal Carcinoma
• TNF
• Chemo-radiotherapy

Interventions

Type	Name	Description
DRUG	5-fu	5-fu: 200mg/m2/d, continuous intravenous infusion on the 1st to 30th day of each cycle.
DRUG	Cisplatin	Cisplatin: 80mg/m2, used on the 1st and 28th day of each cycle.
RADIATION	Radiotherapy	Radiotherapy: Radiotherapy was initiated on day 15 of the first cycle of chemotherapy . GTV: 6810cGy (227 cGy/30f) Or 6996 cGy (212 cGy/ 33F); CTV: 5400-6000 cGy (180-200 cGy/f); Radiotherapy once a day, 5 times a week, a total of 30-33 times, a total of about 6 weeks.
DRUG	TNF	TNF (recombinant human tumor necrosis factor for injection) : 1 million IU (BSA\<2.0m2) or 1.5 million IU (BSA≥2.0m2), dissolved in normal saline 1-2mL, intramuscular, QD, 30 days in the first and third months, once a day.
DRUG	Placebo	Placebo: 1-2ml normal saline, intramuscular injection, QD, once a day, 30 days in the first and third months.

Timeline

• Start date: 2022-07-01
• Primary completion: 2024-07-01
• Completion: 2029-07-01
• First posted: 2022-06-27
• Last updated: 2022-06-27