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NCT04891016
Toripalimab Plus FLOT in Locally Advanced Gastric Cancer
Phase 2 trial testing FLOT combined with toripalimab in Chemotherapy in 60 participants. Currently enrolling.
31 December 2025
Quick facts
| Lead sponsor | Henan Cancer Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 25 June 2021 |
| Primary completion | 31 December 2025 |
| Estimated completion | 31 December 2028 |
| Sites | 1 location across China |
Drugs / interventions tested
- FLOT combined with toripalimab — full drug profile →
Conditions studied
- Chemotherapy — all drugs for Chemotherapy →
- Immune Checkpoint Inhibitor — all drugs for Immune Checkpoint Inhibitor →
- Locally Advanced Gastric Carcinoma — all drugs for Locally Advanced Gastric Carcinoma →
Sponsor
Henan Cancer Hospital
Who can join
Adults 18 to 70, any sex, with Chemotherapy or Immune Checkpoint Inhibitor. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Neoadjuvant chemoimmunotherapy for locally advanced gastric and gastroesophageal junction (G/GEJ) cancer is currently under investigation. Most clinical studies have simply combined chemotherapy with anti-PD-1 therapy without considering the impact of chemotherapy drugs on activated immune cells. We designed this study to explore two different treatment regimens for neoadjuvant chemotherapy in patients with locally advanced G/GEJ cancer. One group received FLOT plus toripalimab on Day 1 of each cycle, every 2 weeks for 4 cycles, followed by surgery; the other group received FLOT plus toripalimab on Day 3 of each cycle, every 3 weeks for 3 cycles, followed by surgery. A total of 69 subjects were enrolled. Preliminary statistical analysis conducted one year after the last subject was enrolled revealed no statistically significant differences in pCR and MPR between the two regimens. The median DFS for both groups has not been reached, and there is no statistically significant difference in DFS between the two groups at present. Further subgroup analysis indicated that among subjects with PD-L1 CPS ≥1, the triweekly group achieved a rate of 42.1%, compared to 29.4% in the biweekly group, with no statistically significant difference between the two groups. However, the incidence of bone marrow suppression was lower in the triweekly group than in the biweekly group. Based on the preliminary findings, we plan to conduct an expanded study and transition to a multicenter clinical trial. This study aims to further validate the efficacy of the triweekly chemoimmunotherapy in patients with PD-L1 CPS ≥1 locally advanced G/GEJ cancer.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Tumor immunotherapies by immune checkpoint inhibitors (ICIs); the pros and cons.
Naimi A, Mohammed RN, Raji A, Chupradit S, et al · · 2022 · cited 350× · PMID 35392976 · DOI 10.1186/s12964-022-00854-y
Verify or expand the search:
- PubMed search for NCT04891016
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT04891016 (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 Henan Cancer Hospital
- Last refreshed: 6 June 2024
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/NCT04891016.
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