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NCT05715931
Perioperative Chemotherapy Plus Trastuzumab Plus Toripalimab in HER2 Positive Locally Advanced Gastric or Esophagogastric Junction Adenocarcinoma
Phase 2 trial testing Toripalimab in Adenocarcinoma of the Stomach in 30 participants. Currently enrolling.
1 March 2025
Quick facts
| Lead sponsor | Yu jiren |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 28 February 2023 |
| Primary completion | 1 March 2025 |
| Estimated completion | 1 March 2028 |
| Sites | 8 locations across China |
Drugs / interventions tested
- Toripalimab (TORIPALIMAB) — full drug profile →
- Trastuzumab (trastuzumab) — full drug profile →
- 5-FU, leucovorin, docetaxel, oxaliplatin (FLOT) — full drug profile →
Conditions studied
- Adenocarcinoma of the Stomach — all drugs for Adenocarcinoma of the Stomach →
- Adenocarcinoma of Esophagogastric Junction — all drugs for Adenocarcinoma of Esophagogastric Junction →
- HER2-positive Gastric Cancer — all drugs for HER2-positive Gastric Cancer →
Sponsor
Yu jiren — full company profile →
Who can join
Adults 18 to 80, any sex, with Adenocarcinoma of the Stomach or Adenocarcinoma of Esophagogastric Junction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is a prospective, single arm, multi-center phase II clinical trial designed to evaluate the efficacy and safety of perioperative chemotherapy with FLOT regimen and trastuzumab in combination with toripalimab in participants with resectable HER2 positive locally advanced gastric or esophagogastric junction adenocarcinoma.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
HER2-Positive Gastric Cancer and Antibody Treatment: State of the Art and Future Developments.
Scheck MK, Hofheinz RD, Lorenzen S. · · 2024 · cited 28× · PMID 38611014 · DOI 10.3390/cancers16071336 -
Additions of trastuzumab to preoperative chemotherapy or chemoimmunotherapy for patients with potentially resectable stage III to IV<sub>B</sub> HER2-positive gastric cancer.
Zhang X, Tian Y, Wang H, Song S, et al · · 2025 · PMID 40755752 · DOI 10.3389/fimmu.2025.1624943
Verify or expand the search:
- PubMed search for NCT05715931
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Toripalimab
Trials testing the same drug.
- NCT07371897 — Toripalimab ± Chemo as Neoadjuvant Therapy in LA-HNSCC: A Phase III Trial · Phase 3 · not yet recruiting
- NCT07423078 — Window of Opportunity in Preserving Laryngeal Function Trial · Phase 2 · recruiting
- NCT07480733 — Phase II Study of JS212/JS213 as Monotherapy and in Combination in Patients With Advanced Malignant Solid Tumors · Phase 2 · not yet recruiting
- NCT07320963 — Chidamide in Combination With Toripalimab and Anlotinib in Recurrent/Metastatic Nasopharyngeal Carcinoma. · Phase 1, PHASE2 · not yet recruiting
- NCT07469956 — Surufatinib Plus mFOLFIRINOX and PD-1 Inhibitor as the Neoadjuvant Therapy for High-risk or Borderline Resectable Pancre · Phase 2 · not yet recruiting
Other recruiting trials for Adenocarcinoma of the Stomach
Currently open trials in the same condition.
- NCT05872685 — Perioperative Chemotherapy Combined With Serplulimab or Placebo for pMMR Locally Advanced Gastric Adenocarcinoma (FOCUS- · Phase 2 · recruiting
- NCT05729646 — Perioperative Chemotherapy Plus Toripalimab for dMMR Locally Advanced Gastric or Esophagogastric Junction Adenocarcinoma · Phase 2 · recruiting
- NCT06121700 — Radiotherapy + Chemoimmunotherapy Followed by Surgery in Patients With Limited Metastatic Gastric or GEJ Cancer · Phase 2 · recruiting
- NCT04878783 — Radiomics and Molecular Expression Predictive Model for Esophago-Gastric Junction and Gastric Cancer TRG · active not recruiting
Other Yu jiren trials
Trials by the same sponsor.
- NCT05872685 — Perioperative Chemotherapy Combined With Serplulimab or Placebo for pMMR Locally Advanced Gastric Adenocarcinoma (FOCUS- · Phase 2 · recruiting
- NCT05970627 — Perioperative Chemotherapy Plus Toripalimab for Epstein-Barr Virus-associated Locally Advanced Gastric or Esophagogastri · Phase 2 · not yet recruiting
- NCT05729646 — Perioperative Chemotherapy Plus Toripalimab for dMMR Locally Advanced Gastric or Esophagogastric Junction Adenocarcinoma · Phase 2 · recruiting
- NCT04515615 — Adjuvant Chemotherapy in Combination With Camrelizumab for Stage III Gastric Cancer (FOCUS-02) · Phase 2 · active not 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 NCT05715931 (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 Yu jiren
- Last refreshed: 19 September 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/NCT05715931.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing