Combining Sintilimab with Chemotherapy and Radiotherapy for Advanced Esophagogastric Junction Cancer
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
This study is testing a new treatment that combines a drug called Sintilimab with chemotherapy and radiation to see if it helps people with advanced esophagogastric junction cancer before surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Wuhan Union Hospital, China Academic / other |
| Drugs / interventions | immunotherapy, Sintilimab, chemotherapy |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT06250894 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of neoadjuvant immunotherapy using Sintilimab, a PD-1 inhibitor, in conjunction with chemotherapy (S-1 and Oxaliplatin) and radiotherapy for patients with locally advanced adenocarcinoma of the esophagogastric junction. Participants will receive this combination treatment before surgical intervention to assess its impact on tumor response. The study aims to improve outcomes for patients with this challenging cancer type by potentially enhancing tumor shrinkage and overall survival rates.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with histologically confirmed locally advanced esophagogastric junction adenocarcinoma who have not received prior anti-tumor treatments.
Not a fit: Patients with known Her-2 positive tumors or those who have previously received immunotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved treatment outcomes and survival rates for patients with locally advanced esophagogastric junction cancer.
How similar studies have performed: While the combination of immunotherapy and chemoradiotherapy is being explored in various cancers, this specific approach for esophagogastric junction adenocarcinoma is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Wuhan, Hubei
- Min Jin — Wuhan, Hubei, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.