Clinical trial · Interventional
Neoadjuvant Sintilimab Plus Chemoradiotherapy for Locally Advanced Adenocarcinoma of Esophagogastric Junction
A Clinical Study of the Efficacy and Safety of Sintilimab in Combination With Chemotherapy (S-1/Oxaliplatin, SOX) and Radiotherapy for the Neoadjuvant Treatment of Locally Advanced Esophagogastric Junction Adenocarcinoma
NCT06250894CI-TRIAL-00073878unknownPhase 2ClinicalTrials.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 study is to access the safety and efficacy of neoadjuvant Immunotherapy (Sintilimab, PD-1 inhibitor) combined with chemotherapy (S-1+Oxaliplatin) and radiotherapy for locally advanced esophagogastric junction adenocarcinoma.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastroesophageal Junction Cancer | — | UNRESOLVED | — |
| Neoadjuvant Chemoradiotherapy | — | UNRESOLVED | — |
| PD-1 | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PD-1inhibitor | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Neoadjuvant immunotherapy-chemoradiotherapy
- description
- This is a one arm study, enrolled locally advanced EGJ patients will receive Sintilimab (PD-1 inhibitor) and combined with preoperative chemoradiotherapy and operation. generic name：PD-1; dosage form：Injection; dosage：200mg (20ml)； frequency：every 3 weeks； duration：3 times before operation and 3-5 times after operation
- interventionNames
- Drug: PD-1inhibitor
Primary outcomes (1)
- measure
- Pathologic Complete Response
- timeFrame
- 10 days after operation
- description
- No malignant tumor cells were detected in the removed specimens including primary tumor and lymph nodes
Secondary outcomes (5)
- measure
- Objective response rate (ORR)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18-70, male and female. * Histologically confirmed locally advanced esophagogastric junction Adenocarcinoma cT3-4aNxM0 (AJCC v8), Siewert typed as type II-III. * No previous anti-tumor treatment. * ECOG score was 0-1. * Expected survival of ≥ 6 months * Adequate organ reserve function. Exclusion Criteria: * Malignant disease other than gastric cancer (excluding radically treated basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or radically resected carcinoma in situ) diagnosed within 5 years. * Known Her-2 positive( IHC 3+ or FISH positve). * Patients have received immunotherapy, such as PD-1 antibody, PD-L1 antibody and CTLA4 antibody * Severe allergic reaction to monoclonal antibody. * Receiving systemic glucocorticoid therapy within 7 days prior to the first dose of the study * Known endoscopic signs of active bleeding from the lesion
References
Publications (0)
Data not yet available
No reference posted for this study.