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NCT05508399
Biomarker Analysis of Tislelizumab Combined With Chemotherapy for Perioperative Treatment of G/GEJ Adenocarcinoma
trial testing DNA panel and RNA Sequencing in Locally Advanced Gastric Adenocarcinoma in 28 participants. Completed in 10 October 2025.
10 January 2024
Quick facts
| Lead sponsor | Xijing Hospital |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 28 |
| Start date | 18 July 2022 |
| Primary completion | 10 January 2024 |
| Estimated completion | 10 October 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- DNA panel and RNA Sequencing
Conditions studied
- Locally Advanced Gastric Adenocarcinoma — all drugs for Locally Advanced Gastric Adenocarcinoma →
- PD-1 — all drugs for PD-1 →
Sponsor
Xijing Hospital
Who can join
Adults 18 to 80, any sex, with Locally Advanced Gastric Adenocarcinoma or PD-1. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
G/GEJ adenocarcinoma is one of the most common malignant tumors in China, ranking the fifth highest incidence and third highest mortality worldwide. Currently, surgical resection is the preferred treatment for G/GEJ adenocarcinoma, while the 5-year survival rate of patients is lower than 25%. Compared with surgical resection, immunotherapy is proved to be able to effectively prolong the survival time of patients. On one hand, with the continuous promotion of immunotherapy drugs, the exploration of neoadjuvant application of immunotherapy in G/GEJ adenocarcinoma has become a hotspot in recent years. It's also on their way that clinical trials of programmed death receptor-1 (PD-1), programmed death ligand-1 (PD-L1) and other immune checkpoints are carried out. On the other hand, the research found that although the curative effect of immune therapy seems better, the present G/GEJ adenocarcinoma immunotherapy marker researches mainly focused on the late stage of the cancer, with few studies of immune markers of neoadjuvant therapy for G/GEJ adenocarcinoma. Additionally, it's not quite feasible for single biomarkers to predict the immune treatment effect precisely. Therefore, combined with clinicopathology and therapeutic effects, this study is aimed to construct the efficacy prediction model of anti-PD-1 antibody together with chemotherapy for G/GEJ adenocarcinoma, by detecting RNA expression. Furthermore, this study will perform drug sensitivity test and bio-molecular test on patient derived organoid model to validate the biomarkers found from biological specimens.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Organoids: development and applications in disease models, drug discovery, precision medicine, and regenerative medicine.
Yao Q, Cheng S, Pan Q, Yu J, et al · · 2024 · cited 40× · PMID 39309690 · DOI 10.1002/mco2.735 -
The application of organoids in investigating immune evasion in the microenvironment of gastric cancer and screening novel drug candidates.
Kan L, Yu Y, Wang Y, Shi L, et al · · 2025 · cited 6× · PMID 40287758 · DOI 10.1186/s12943-025-02328-4 -
RNA modifications in cancer.
Wu H, Chen S, Li X, Li Y, et al · · 2025 · cited 5× · PMID 39802639 · DOI 10.1002/mco2.70042 -
Immune organoid for cancer immunotherapy.
Wang XH, Wang WY, Sun ZJ. · · 2025 · cited 2× · PMID 40698131 · DOI 10.1016/j.apsb.2025.04.031
Verify or expand the search:
- PubMed search for NCT05508399
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other Xijing Hospital trials
Trials by the same sponsor.
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- NCT07466303 — Serplulimab Combined With Trastuzumab Rezetecan as Neoadjuvant Therapy for Triple-Negative Breast Cancer · Phase 2 · not yet recruiting
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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 NCT05508399 (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 Xijing Hospital
- Last refreshed: 4 December 2025
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/NCT05508399.
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