Last reviewed · How we verify
NCT05844371
Efficacy and Safety of Tirelizumab Plus Chemotherapy Versus Chemotherapy Alone in Patients With Lymph Node Positive Gastric Cancer After Surgery
Phase 2 trial testing tirelizumab in Gastric Cancer in 60 participants. Status unknown.
1 June 2023
Quick facts
| Lead sponsor | Yixing People's Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 1 April 2021 |
| Primary completion | 1 June 2023 |
| Estimated completion | 1 April 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- tirelizumab — full drug profile →
- chemotherapy with oxaliplatin + heroda — full drug profile →
Conditions studied
- Gastric Cancer — all drugs for Gastric Cancer →
Sponsor
Yixing People's Hospital
Who can join
Adults 30 to 90, any sex, with Gastric Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Lymph node positive patients after D2 radical surgery for gastric cancer, who started to be treated at Yixing people's Hospital in April 2021, were selected and enrolled into the study group according to the patients' wishes: immune (tirelizumab) combined with chemotherapy (XELOX regimen) or control group: chemotherapy alone (XELOX regimen). Each enrolled patient signed an informed consent form approved by the ethics committee, signed, and dated. Efficacy and adverse effects were assessed in both groups.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Overcoming immunotherapy resistance in gastric cancer: insights into mechanisms and emerging strategies.
Luo D, Zhou J, Ruan S, Zhang B, et al · · 2025 · cited 27× · PMID 39915459 · DOI 10.1038/s41419-025-07385-7 -
Clinical efficacy and safety of adjuvant immunotherapy (Tislelizumab) plus chemotherapy vs. adjuvant chemotherapy alone in lymph node-positive patients with gastric cancer after D2 radical resection: a prospective, 2-arm, phase II study.
Shi JW, Zhou Y, Wu S. · · 2023 · cited 5× · PMID 37975371 · DOI 10.26355/eurrev_202311_34324 -
Programmed death receptor-1/programmed death-ligand 1 inhibitors: Clinical progress and biomarker exploration in gastric cancer.
Shi J, Song X, Gao Z, Dai D, et al · · 2024 · cited 3× · PMID 39640802 · DOI 10.1016/j.heliyon.2024.e38710
Verify or expand the search:
- PubMed search for NCT05844371
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of tirelizumab
Trials testing the same drug.
- NCT05638984 — Low Dose Decitabine in Combination With Tirelizumab Comparison of Tirelizumab in the First-line Treatment of Advanced Es · Phase 2 · unknown
Other recruiting trials for Gastric Cancer
Currently open trials in the same condition.
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- NCT07431281 — Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Meta · Phase 3 · recruiting
- NCT07448493 — Local Treatment Strategies for Brain Metastases of Gastric and Esophageal Cancer · 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 NCT05844371 (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 Yixing People's Hospital
- Last refreshed: 6 May 2023
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/NCT05844371.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing