NCT03668366 is a Phase 2 clinical trial of S-1 in Nasopharyngeal Carcinoma, sponsored by Fudan University.

Who is sponsoring NCT03668366?

NCT03668366 is sponsored by Fudan University.

What drugs are being tested in NCT03668366?

Interventions in NCT03668366: S-1.

What condition does NCT03668366 study?

NCT03668366 studies Nasopharyngeal Carcinoma.

Is NCT03668366 still recruiting?

NCT03668366 is currently completed. Last updated 11 February 2021.

Last reviewed 2021-02-11 · How we verify

NCT03668366

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

S-1 Combined With IMRT Concurrent Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma

Completed Phase 2 Last updated 11 February 2021

What this trial tests

Phase 2 trial testing S-1 in Nasopharyngeal Carcinoma in 133 participants. Completed in 1 August 2020.

Timeline

1 August 2013

Primary endpoint
1 December 2018

1 August 2020

Quick facts

Lead sponsor	Fudan University
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	133
Start date	1 August 2013
Primary completion	1 December 2018
Estimated completion	1 August 2020
Sites	1 location across China

Drugs / interventions tested

S-1 — full drug profile →

Conditions studied

Nasopharyngeal Carcinoma — all drugs for Nasopharyngeal Carcinoma →

Sponsor

Fudan University

Who can join

Adults 18 to 80, any sex, with Nasopharyngeal Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a prospective phase II trial which is designed to evaluate the efficacy and safety of IMRT combined with S-1 CCRT for locally advanced NPC. Eligibility criteria include histologically confirmed locally advanced NPC according to the American Joint Committee on Cancer (AJCC) Staging System (the eighth edition); Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; at least one measurable lesion based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1; normal complete blood count, normal hepatic function and normal renal function. Prior induction chemotherapy with platinum was allowed. Exclusion criteria include previous radiotherapy, a history of any other type of malignancy; pregnancy or lactation; allergy to S-1; obvious dysfunction of liver, renal, cardiac or lung function; uncontrolled infection; systemic metastasis or distant metastasis; patients with severe gastrointestinal diseases, and patients with mental disorders affecting patient participation in trial judgement. The full-set pretreatment evaluation will be performed to every patient.All patients in this study will receive intensity-modulated radiation therapy (IMRT). During the IMRT course, S-1 will be administered orally according to body surface area.The dose modifications of S-1 will not be permitted during concurrent chemotherapy unless progression of the disease, toxicities of grade 4 or patient's refusal. The primary endpoints of this study is adverse events (AE) rate and progression-free survival (PFS).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of S-1

Trials testing the same drug.

NCT07515625 — Efficacy of Sintilimab Combined With Bevacizumab and XELOX/SOX in Initially Unresectable AFP-positive Gastric/Gastroesop · Phase 2 · not yet recruiting
NCT07374250 — Perioperative Ivonescimab Plus S-1 and Oxaliplatin (SOX) for Locally Advanced Gastric or GEJ Adenocarcinoma · Phase 2 · not yet recruiting
NCT07384234 — SHR-1701 Combined With Chemotherapy for Gastric or Gastroesophageal Junction Adenocarcinoma With Peritoneal Metastasis · Phase 2 · not yet recruiting
NCT07243938 — Phase II Basket Trial: Zanidatamab Plus Tislelizumab in HER2-Positive GI Tumors (UNION-HER2-BASKET) · Phase 2 · not yet recruiting
NCT07018063 — Neoadjuvant Nab-Paclitaxel Plus Oxaliplatin, S-1, and Sintilimab in Early-Onset Resectable Gastric Cancer · Phase 2 · not yet recruiting

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 Fudan University trials

Trials by the same sponsor.

NCT06196671 — Oncolytic Virus Plus PD-1 Inhibitor to Patients With Advanced Pancreatic Cancer · Phase 2 · not yet recruiting
NCT07423611 — ctDNA-Guided Chemotherapy Omission With Ribociclib Plus Endocrine Therapy in HR-Positive/HER2-Negative Breast Cancer · Phase 2 · not yet recruiting
NCT07410559 — Neoadjuvant Imlunestrant Plus Abemaciclib Treatment Guided by Ki67 Index After 2 Weeks for ER-Positive HER2-Negative Bre · Phase 2 · not yet recruiting
NCT07490119 — Becotatug Vedotin Combined With Cetuximab in the Later-line Treatment of Metastatic RAS Wild-type Colorectal Cancer · Phase 2 · not yet recruiting
NCT07497919 — A Study of Becotatug Vedotin Combined With Pucotenlimab in the Treatment of EGFR-Positive Advanced Penile Cancer · Phase 2 · 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 NCT03668366 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Fudan University
Last refreshed: 11 February 2021

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/NCT03668366.

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