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

PHASE2/PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

172

Participants

Timeline

Start Date

July 1, 2022

Primary Completion Date

July 1, 2024

Study Completion Date

July 1, 2029

Conditions
Nasopharyngeal CarcinomaTNFChemo-radiotherapy
Interventions
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.

All Listed Sponsors
collaborator

Shanghai Weike Bioscience Co., Ltd.

UNKNOWN

lead

Sun Yat-sen University

OTHER

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 | Biotech Hunter | Biotech Hunter