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NCT04358354
Triplet Combination of Cytotoxics as First-line Treatment for Metastatic Gastric Cancer
Phase 3 trial testing Irinotecan in Metastatic Gastric Cancer in 388 participants. Status unknown.
31 December 2023
Quick facts
| Lead sponsor | Sixth Affiliated Hospital, Sun Yat-sen University |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 388 |
| Start date | 22 October 2020 |
| Primary completion | 31 December 2023 |
| Estimated completion | 31 December 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- Irinotecan (irinotecan) — full drug profile →
- Oxaliplatin (Oxaliplatin) — full drug profile →
- 5-fluorouracil
Conditions studied
- Metastatic Gastric Cancer — all drugs for Metastatic Gastric Cancer →
Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Who can join
Adults 18 to 75, any sex, with Metastatic Gastric Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This parallel, randomized, open-label study will evaluate the effect on overall survival of irinotecan on oxaliplatin and 5-fluorouracil (5-FU) in patients with HER2-negative and pMMR metastatic gastric cancer. Irinotecan will be administered as intravenous infusion of 150 mg/m2 every 2 weeks. Oxaliplatin will be given 85 mg/m2 and 5-FU will be given 400mg/m2 iv and 2400mg/m2 civ 48 hours fortnightly. Treatment will continue until disease progress or untolerable toxicity appears. The target sample size is 350-400 patients.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Multimodality Treatment in Metastatic Gastric Cancer: From Past to Next Future.
Parisi A, Porzio G, Ficorella C. · · 2020 · cited 17× · PMID 32932914 · DOI 10.3390/cancers12092598
Verify or expand the search:
- PubMed search for NCT04358354
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Metastatic Gastric Cancer
Currently open trials in the same condition.
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Other Sixth Affiliated Hospital, Sun Yat-sen University trials
Trials by the same sponsor.
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- NCT07176182 — Clinical Trial of Neoadjuvant mFOLFOX Plus Alvenor for LARC Patients With High YWHAB Expression · Phase 2 · not yet recruiting
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- NCT07344428 — Efficacy and Safety of CDED With Anti-TNF-α Biologics in Crohn's Disease: A Randomized Trial · NA · not yet recruiting
- NCT07328958 — Effect of Titrated Administration of Ciprofol on Perioperative Hypotension in Elderly Patients Undergoing Laparoscopic A · NA · recruiting
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 NCT04358354 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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 Sixth Affiliated Hospital, Sun Yat-sen University
- Last refreshed: 19 July 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/NCT04358354.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing