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The purpose of this study is to explore the effectiveness and safety of immunotherapy (Adebrelimab, a PD-L1 inhibitor) combined with standard chemotherapy (XELOX) in the perioperative treatment of resectable esophagogastric junction adenocarcinoma.
The study will evaluate the efficacy and safety of the immunotherapy (Adebrelimab) combined with standard chemotherapy (XELOX) in the perioperative treatment of resectable esophagogastric junction adenocarcinoma. Potential study participants will be assessed for eligibility during a 28-day screening period that includes central verification of clinical stage and eligibility. Eligible patients will be receive perioperative treatment with adebrelimab with XELOX. Location of the primary (GEJ type I vs. GEJ type II/III vs. stomach), and PD-L1-status (CPS≥5 vs. CPS<5). Microsatellite Instability (MSI-H vs MSI-L) will be will be given special attention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental arm | Experimental | Patients will receive Immunotherapy (Adebrelimab, PD-L1 inhibitor) combined with XELOX chemotherapy (Capecitabine + Oxaliplatin) therapy in four 3-week treatment cycles with imaging assessment every 2 cycles. After treatment response evaluation, patients will receive resection within 4-8 weeks. Following surgery, patients will receive four further 3-week cycles of Adebrelimab + XELOX after 4-12 weeks of resection. Patients will then receive 10 additional 3-week treatment cycles with Adebrelimab alone. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adebrelimab (anti-PD-L1) + XELOX | Drug | Adebrelimab: 1200mg, i.v., each infusion lasts 30-60 minutes and is administered on the first day of each cycle (3 weeks). Capecitabine: 1000mg/m2 , bid, orally, from day 1 to day 14 of each cycle (3 weeks). Oxaliplatin: 130mg/m2, i.v., each infusion is administered on the first day of each cycle (3 weeks). |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological complete response rate (ITT) | The proportion of subjects with no cancer cells in the primary tumor and lymph node specimens (ypT0N0) | From date of enrolment until surgical resection, an average of 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital, Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200025 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39905364 | Derived | Li Y, Cao Y, Wang X, Li C, Zhao L, Li H. Effects of perioperative treatment of resectable adenocarcinoma of esophagogastric junction by immunotherapy (Adebrelimab) combined with chemotherapy (XELOX): protocol for a single-center, open-labeled study (AEGIS trial, neoadjuvant immunochemotherapy). BMC Cancer. 2025 Feb 4;25(1):198. doi: 10.1186/s12885-025-13589-z. |
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| ID | Term |
|---|---|
| C519688 | XELOX |
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