Clinical trial · Observational
A Benefit Population Atlas of nICT Versus nCT for LAGC
Identifying Optimal Responders: A Benefit Population Atlas of Neoadjuvant Immunochemotherapy Versus Chemotherapy for Locally Advanced Gastric Cancer
NCT07098104CI-TRIAL-00092960completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this observational study is to evaluate the impact of different neoadjuvant therapies on patients with locally advanced gastric cancer. The primary question it aims to address is: Which patient populations benefit most from neoadjuvant immunochemotherapy versus neoadjuvant chemotherapy in locally advanced gastric cancer?
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Immunotherapy | Drug | Immunotherapy | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- neoadjuvant chemotherapy
- description
- The nCT group included two subgroups: nCT2 (SOX/XELOX) and nCT3 (FLOT: docetaxel 50mg/m² + oxaliplatin 85mg/m² + leucovorin 200mg/m² d1 + fluorouracil 2600mg/m² 48h CIV q2w; or DCF: docetaxel 75mg/m² + cisplatin 75mg/m² d1 + fluorouracil 750mg/m² d1-5 q3w).
- interventionNames
- Drug: Immunotherapy
- label
- neoadjuvant immunochemotherapy
- description
- The nICT group received PD-1 inhibitors (sintilimab 200mg, tislelizumab 200mg, or nivolumab 240mg, all iv q3w) combined with two-drug chemotherapy (SOX: oxaliplatin 130mg/m² d1 + S-1 40-60mg bid d1-14; or XELOX: oxaliplatin 130mg/m² d1 + capecitabine 1000mg/m² bid d1-14, both q3w).
- interventionNames
- Drug: Immunotherapy
Primary outcomes (2)
- measure
- PCR
- timeFrame
- 2019.11-2023.12
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: Eligible patients had pathologically confirmed adenocarcinoma, imaging-confirmed resectable LAGC (cT2-4aN0-3M0, AJCC 8th), no distant metastases, and completed protocol-specified neoadjuvant therapy (nICT: PD-1/PD-L1 inhibitors plus two-drug chemotherapy; nCT: two-drug \[SOX/XELOX\] or three-drug \[FLOT/DCF\] chemotherapy) with ECOG 0-1. Exclusion Criteria: Exclusion criteria included incomplete neoadjuvant therapy, non-radical surgery, other malignancies, active autoimmune diseases/immunosuppressant use, missing key data, or inadequate follow-up (\<3 months without documented events).
References
Publications (0)
Data not yet available
No reference posted for this study.