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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 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2022-06-27

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Shanghai Weike Bioscience Co., Ltd.

    collaborator UNKNOWN

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Yun-fei Xia, MD · Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2024-07-01
Completion
2029-07-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05433597 on ClinicalTrials.gov