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NCT03403101
The Combination Chemotherapy of SIRIOX as First- or Second-Line Chemotherapy for Pancreatic Cancer
Phase 2 trial testing S1 in Carcinoma, Pancreatic Ductal in 65 participants. Status unknown.
31 December 2023
Quick facts
| Lead sponsor | Fudan University |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 65 |
| Start date | 1 July 2020 |
| Primary completion | 31 December 2023 |
| Estimated completion | 1 July 2024 |
| Sites | 2 locations across China |
Drugs / interventions tested
- S1 — full drug profile →
- Oxaliplatin (Oxaliplatin) — full drug profile →
- Irinotecan (irinotecan) — full drug profile →
Conditions studied
- Carcinoma, Pancreatic Ductal — all drugs for Carcinoma, Pancreatic Ductal →
Sponsor
Fudan University
Who can join
Adults 18 to 75, any sex, with Carcinoma, Pancreatic Ductal. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Pancreatic cancer represents the most lethal of the common malignancies with a 5-year survival rate of less than 5%. For patients who are eligible for potentially curative resection, despite mortality and morbidity rates after surgery have improved, the recurrence rate is up to 85% within 2 years. FOLFIRINOX (fluoropyrimidine/leucovorin plus irinotecan and oxaliplatin) has been proved to significantly improve the prognosis and is recommended as first line treatment in patients with advanced pancreatic cancer. However, the regimen is limited due to the severe adverse effects. Thus, the investigators replaced 5-FU and leucovorin in the FOLFIRINOX regimen with oral S-1, a new oral fluoropyrimidine derivative which was proved to be the well-tolerated and effectively in large III phase randomized clinical trial, to form the SIRIOX regimen. A phase I clinical trial from Japan found that SOXIRI (S-1, oxaliplatin and irinotecan) works in patients with advanced pancreatic cancer. In this study, the researchers intend to investigate the activity and safety of the combination of this regimen in patients with advanced pancreatic cancer, as first- or second-line chemotherapy.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Modified FOLFIRINOX for resected pancreatic cancer: Opportunities and challenges.
Yang F, Jin C, Fu DL, Warshaw AL. · · 2019 · cited 9× · PMID 31249443 · DOI 10.3748/wjg.v25.i23.2839
Verify or expand the search:
- PubMed search for NCT03403101
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Fudan University trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03403101 (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 Fudan University
- Last refreshed: 9 April 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/NCT03403101.
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