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NCT06576921
Efficacy and Safety of Serplulimab Combined With Chemotherapy as Neoadjuvant Treatment for Locally Advanced Gastric Cancer or Adenocarcinoma of Esophagogastric Junction
Phase 2 trial testing Serplulimab Combined With Chemotherapy in Stomach Neoplasms in 116 participants. Currently enrolling.
1 March 2026
Quick facts
| Lead sponsor | Xijing Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 116 |
| Start date | 15 November 2024 |
| Primary completion | 1 March 2026 |
| Estimated completion | 30 September 2026 |
| Sites | 4 locations across China |
Drugs / interventions tested
- Serplulimab Combined With Chemotherapy — full drug profile →
- Placebo combined with Chemotherapy — full drug profile →
Conditions studied
- Stomach Neoplasms — all drugs for Stomach Neoplasms →
- Immune Checkpoint Inhibitors — all drugs for Immune Checkpoint Inhibitors →
Sponsor
Xijing Hospital
Who can join
Adults 18 to 75, any sex, with Stomach Neoplasms or Immune Checkpoint Inhibitors. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a multicenter, double-blind, randomized, phase 2 trial to investigate the efficacy and safety of serlulimab combined with nab-paclitaxel plus SOX versus nab-paclitaxel plus SOX alone as neoadjuvant treatment for locally advanced GC or AEG. The goal of this clinical trial is to learn if serlulimab combined with nab-paclitaxel plus SOX as neoadjuvant treatment for locally advanced AEG/GC. It will also learn about the safety of serlulimab combined with nab-paclitaxel plus SOX. The main questions it aims to answer are: Does serlulimab increase the pCR of participants with locally advanced AEG/GC ? What medical problems do participants have when taking serlulimab? Researchers will compare to a placebo (a look-alike substance that contains no drug) to see if serlulimab combined with nab-paclitaxel plus SOX as neoadjuvant treatment for locally advanced AEG/GC. Participants will: Eligible patients were randomly assigned to receive serlulimab (4.5 mg intravenously on day 1) combined with chemotherapy (nap-paclitaxel 260 mg/m2 intravenously on days 1, OXA 130mg/ /m2, intravenously on days 1, and S-1 40 to 60 mg orally twice daily depending on BSA on days 1 to 14) or chemotherapy alone every 3 weeks for 3 preoperative cycles followed by 3 postoperative cycles. All patients will be followed for survival.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06576921
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Stomach Neoplasms
Currently open trials in the same condition.
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- NCT07504913 — Spanish Validation of KOQUSS-40 Questionnaire: Assessing QoL of Gastric Cancer Patients After Gastrectomy: SPQUSS-41 · recruiting
- NCT07113340 — Carina™ Surgical Platform for Minimal Radical Gastrectomy · NA · active not recruiting
- NCT06630130 — Perioperative Therapies in Locally Advanced Unresectable Gastric Cancer · Phase 2 · recruiting
Other Xijing Hospital trials
Trials by the same sponsor.
- NCT07532096 — Extended Sentinel Lymph Node Biopsy With Methylene Blue Single Tracer Post-Neoadjuvant Therapy for Node-Positive Breast · NA · not yet recruiting
- NCT07519018 — TIS for Drug Resistant TLE · NA · not yet recruiting
- NCT07518992 — Correlation Between Preoperative Sleep and Postoperative Brain and Renal Dysfunction · not yet recruiting
- NCT07466303 — Serplulimab Combined With Trastuzumab Rezetecan as Neoadjuvant Therapy for Triple-Negative Breast Cancer · Phase 2 · not yet recruiting
- NCT07474142 — A Multicenter, Prospective Study on the Prognostic Value of PSMA PET in Patients With Newly Diagnosed, Treatment-naïve P · 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 NCT06576921 (US National Library of Medicine, public domain)
- 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: 23 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/NCT06576921.
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