NCT02269904 is a Phase 2 clinical trial of Fluorouracil Implants in DSF, sponsored by Jiangsu Simcere Pharmaceutical Co., Ltd..

Who is sponsoring NCT02269904?

NCT02269904 is sponsored by Jiangsu Simcere Pharmaceutical Co., Ltd..

What drugs are being tested in NCT02269904?

Interventions in NCT02269904: Fluorouracil Implants, Xelox regimes.

Is NCT02269904 still recruiting?

NCT02269904 is currently status unknown. Last updated 17 October 2014.

Last reviewed 2014-10-17 · How we verify

NCT02269904

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

Fluorouracil Implants（SinoFuan®）Used for Intraperitoneal Chemotherapy During Operation for Intraperitoneal Chemotherapy During Operation for Treatment of Phase III Gastric Cancer, Randomized, Controlled, Multicentres Open Study.

Status unknown Phase 2 Last updated 17 October 2014

What this trial tests

Phase 2 trial testing Fluorouracil Implants in DSF in 120 participants. Status unknown.

Timeline

1 April 2014

Primary endpoint
1 April 2018

1 June 2018

Quick facts

Lead sponsor	Jiangsu Simcere Pharmaceutical Co., Ltd.
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	120
Start date	1 April 2014
Primary completion	1 April 2018
Estimated completion	1 June 2018
Sites	1 location across China

Drugs / interventions tested

Fluorouracil Implants — full drug profile →
Xelox regimes — full drug profile →

Conditions studied

DSF — all drugs for DSF →

Sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd. — full company profile →

Who can join

Adults 18 to 70, any sex, with DSF. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

DFS (Disease Free Survival)
Time frame: 3 year
During 3 years of monitoring period, any cancer relapse will be recorded

Sponsor's own description

SinoFuan is a kind of Fluorouracil Implants for intraperitoneal chemotherapy during operation for treatment of gastric cancer. The indication has bee approved by Chinese FDA. The study is a post-marketing study. The subjects will be divided into two groups (Group A and Group B ). The subject in Group A will receive D2 radical gastrectomy(R0),Sinofuan during operation and 6 cycles of Xelox adjuvant chemotherapy.The subject in Group B will receive D2 radical gastrectomy(R0),and 6 cycles of Xelox adjuvant chemotherapy. The subject's benefits from SinoFuan will be analyzed through comparing 3 years DFS of two groups.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Trial Watch: Immunogenic cell death inducers for anticancer chemotherapy.
Pol J, Vacchelli E, Aranda F, Castoldi F, et al · · 2015 · cited 238× · PMID 26137404 · DOI 10.1080/2162402x.2015.1008866
Hyperthermic intraperitoneal chemotherapy in prevention of gastric cancer metachronous peritoneal metastases: a systematic review.
Reutovich MY, Krasko OV, Sukonko OG. · · 2021 · cited 17× · PMID 33968422 · DOI 10.21037/jgo-20-129
Intraperitoneal Chemotherapy Using Fluorouracil Implants Combined With Radical Resection and Postoperative Adjuvant Chemotherapy for Stage III Gastric Cancer: A Multi-Center, Randomized, Open-Label, Controlled Clinical Study.
Xu Y, Zhang R, Li C, Sun Z, et al · · 2021 · cited 7× · PMID 34307140 · DOI 10.3389/fonc.2021.670651
Role of prophylactic HIPEC in non-metastatic, serosa-invasive gastric cancer: a literature review.
Kunte AR, Parray AM, Bhandare MS, Solanki SL. · · 2022 · cited 4× · PMID 36159214 · DOI 10.1515/pp-2022-0104

Verify or expand the search:

Other Jiangsu Simcere Pharmaceutical Co., Ltd. trials

Trials by the same sponsor.

NCT07345364 — A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics · Phase 1 · not yet recruiting
NCT07357610 — An Open-Label Drug Interaction Clinical Study to Evaluate Itraconazole, Rifampin, Midazolam and SIM0270 in Chinese Healt · Phase 1 · recruiting
NCT07175233 — A Phase 2 Study to Evaluate the Efficacy, Safety of SIM0278 in Subjects With Moderate to Severe Atopic Dermatitis · Phase 2 · not yet recruiting
NCT06686745 — Study of SIM0508 Alone and in Combination in Patients With Advanced Solid Tumors · Phase 1 · recruiting
NCT06680921 — A Study of SIM0270 Combined With Everolimus vs. Treatment of Physician's Choice in Patients With ER+/HER2- Advanced Brea · Phase 3 · 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 NCT02269904 (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 Jiangsu Simcere Pharmaceutical Co., Ltd.
Last refreshed: 17 October 2014

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/NCT02269904.

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