NCT05433597 is a Phase 2, PHASE3 clinical trial of 5-fu in Nasopharyngeal Carcinoma, sponsored by Sun Yat-sen University.

Who is sponsoring NCT05433597?

NCT05433597 is sponsored by Sun Yat-sen University.

What drugs are being tested in NCT05433597?

Interventions in NCT05433597: 5-fu, Cisplatin, Radiotherapy, TNF, Placebo.

What condition does NCT05433597 study?

NCT05433597 studies Nasopharyngeal Carcinoma, TNF, Chemo-radiotherapy.

Is NCT05433597 still recruiting?

NCT05433597 is currently not yet recruiting. Last updated 27 June 2022.

Last reviewed 2022-06-27 · How we verify

NCT05433597

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Not yet recruiting Phase 2, PHASE3 Last updated 27 June 2022

What this trial tests

Phase 2, PHASE3 trial testing 5-fu in Nasopharyngeal Carcinoma in 172 participants. Not yet recruiting.

Timeline

1 July 2022

Primary endpoint
1 July 2024

1 July 2029

Quick facts

Lead sponsor	Sun Yat-sen University
Phase	Phase 2, PHASE3
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	172
Start date	1 July 2022
Primary completion	1 July 2024
Estimated completion	1 July 2029

Drugs / interventions tested

5-fu (5-fu) — full drug profile →
Cisplatin (cisplatin) — full drug profile →
Radiotherapy — full drug profile →
TNF — full drug profile →
Placebo

Conditions studied

Nasopharyngeal Carcinoma — all drugs for Nasopharyngeal Carcinoma →
TNF — all drugs for TNF →
Chemo-radiotherapy — all drugs for Chemo-radiotherapy →

Sponsor

Sun Yat-sen University

Who can join

Adults 18 to 60, any sex, with Nasopharyngeal Carcinoma or TNF. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Radiation-induced tumor immune microenvironments and potential targets for combination therapy.
Guo S, Yao Y, Tang Y, Xin Z, et al · · 2023 · cited 136× · PMID 37208386 · DOI 10.1038/s41392-023-01462-z

Verify or expand the search:

Other trials of 5-fu

Trials testing the same drug.

NCT05780294 — A Multi-center, Randomized, Double-blind, Phase III Clinical Trial of Leucogen Versus Placebo on Leukocyte and Platelet · Phase 3 · not yet recruiting
NCT04164238 — Neoadjuvant Anti-PD-1 Antibody (Toripalimab) or Combined With Chemotherapy in HNSCC Patients · Phase 2 · unknown
NCT03703063 — Alternative Neoadjuvant Chemotherapy in Resectable and Borderline Resectable Pancreatic Cancer · Phase 1 · unknown
NCT03020329 — Induction Chemotherapy in Young Patients With Locoregionally Advanced Nasopharyngeal Carcinoma · Phase 2 · unknown

Other recruiting trials for Nasopharyngeal Carcinoma

Currently open trials in the same condition.

NCT06059261 — Envafolimab Combined With Chemoradiotherapy and Recombinant Human Endostatin for LA-NPC. · Phase 2 · recruiting
NCT07328854 — 40.2Gy Versus 49.2Gy Radiotherapy in Low-Risk Target Volume for Chemosensitive Stage II Nasopharyngeal Carcinoma · Phase 3 · recruiting
NCT06912711 — TN Induction and Adjuvant Therapy for Resectable Local Recurrent Nasopharyngeal Carcinoma · Phase 2 · recruiting
NCT07000643 — Phase III Non-Inferiority Trial of Proton Versus Photon Therapy for Nasopharyngeal Carcinoma · Phase 3 · recruiting
NCT06682442 — Induction Chemotherapy Response-Guided Radiation for EBV-Associated Nasopharyngeal Carcinoma · NA · recruiting

Other Sun Yat-sen University trials

Trials by the same sponsor.

NCT07255612 — Bone Marrow Protection, Safety, Efficacy of Trilaciclib and Eribulin in Locally Advanced or Metastatic TNBC(Triple-negat · Phase 2 · not yet recruiting
NCT07371897 — Toripalimab ± Chemo as Neoadjuvant Therapy in LA-HNSCC: A Phase III Trial · Phase 3 · not yet recruiting
NCT07489703 — SHR-A1811 + AK112 in HER2-Altered Advanced/Metastatic NSCLC · Phase 2 · not yet recruiting
NCT07528209 — Neoadjuvant CAPOX With or Without Pucotenlimab Plus Selective Radiotherapy for Locally Advanced Rectal Cancer · Phase 3 · recruiting
NCT07522281 — Evaluation of an Undisturbed Embryo Culture System for Embryo Development in IVF/ICSI Cycles · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05433597 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sun Yat-sen University
Last refreshed: 27 June 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05433597.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing