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NCT06939439
Using ctDNA to Guide Treatment Decisions for Stage III Gastric Cancer
Phase 3 trial testing Tislelizumab + SOX Chemotherapy in Gastric Cancer Stage III in 416 participants. Participants enrolled and being followed up; not accepting new ones.
31 December 2026
Quick facts
| Lead sponsor | The First Affiliated Hospital with Nanjing Medical University |
|---|---|
| Phase | Phase 3 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 416 |
| Start date | 1 December 2024 |
| Primary completion | 31 December 2026 |
| Estimated completion | 31 December 2029 |
| Sites | 1 location across China |
Drugs / interventions tested
- Tislelizumab + SOX Chemotherapy — full drug profile →
- SOX Chemotherapy — full drug profile →
Conditions studied
- Gastric Cancer Stage III — all drugs for Gastric Cancer Stage III →
Sponsor
The First Affiliated Hospital with Nanjing Medical University
Who can join
Adults 18 to 80, any sex, with Gastric Cancer Stage III. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this randomized, controlled phase III clinical trial is to evaluate whether combining Tislelizumab with standard SOX chemotherapy improves disease-free survival (DFS) compared to chemotherapy alone in patients with stage III gastric or gastroesophageal junction adenocarcinoma who are ctDNA-MRD positive after surgery. The study will enroll 416 patients across multiple centers and will compare outcomes between two groups: patients receiving tislelizumab plus SOX chemotherapy and those receiving standard SOX chemotherapy alone. The primary questions to be addressed are whether the combination therapy improves 1-year DFS rates and whether it demonstrates an acceptable safety profile. Participants will provide tissue and blood samples for ctDNA-MRD testing, undergo postoperative adjuvant therapy (chemotherapy ± immunotherapy), and complete regular follow-up visits to monitor treatment response and safety. The trial will assess key outcomes, including DFS, overall survival (OS), and ctDNA clearance rates, to determine the clinical benefit and safety of tislelizumab in this population.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06939439
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Gastric Cancer Stage III
Currently open trials in the same condition.
- NCT07257575 — A Randomized Controlled Study of Serplulimab Combined With Chemotherapy for Locally Advanced Gastric Adenocarcinoma · Phase 2 · active not recruiting
- NCT06755554 — Investigation of Impact of Indocyanine Green on Volume of Lymphadenectomy in Resectable Gastric Cancer · Phase 3 · recruiting
- NCT06042998 — A Multicenter, RCT Study of the Clinical Efficacy of Robotic and Laparoscopic Gastrectomy in Neoadjuvant Gastric Cancer · NA · recruiting
- NCT04515615 — Adjuvant Chemotherapy in Combination With Camrelizumab for Stage III Gastric Cancer (FOCUS-02) · Phase 2 · active not recruiting
Other The First Affiliated Hospital with Nanjing Medical University trials
Trials by the same sponsor.
- NCT07377981 — An Exploratory Study of the Efficacy and Safety of Esketamine and Dexmedetomidine in Non-Intubated ICU Patients With Hyp · Phase 4 · not yet recruiting
- NCT07523789 — Comparison of Chemotherapy and Immunotherapy in Neoadjuvant Therapy for TNBC · not yet recruiting
- NCT07464756 — SHR-1701 With or Without Apatinib in Combination With Chemotherapy as Neoadjuvant Therapy for Gastric Cancer · Phase 2 · not yet recruiting
- NCT07482826 — Full-Endoscopic Decompression vs. Endoscopic Lumbar Fusion for Middle-Aged and Older Adults With Spinal Stenosis · NA · 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 NCT06939439 (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 The First Affiliated Hospital with Nanjing Medical University
- Last refreshed: 1 July 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/NCT06939439.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing