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The goal of this prospective, open-label, single-center clinical study is to learn about the efficacy and safety of aderbelimab combined with chemotherapy in the perioperative treatment of esophageal and esophagogastric junction cancer. The main question it aims to answer are:prediction for pCR after perioperative adebrelimab and chemotherapy in esophageal and esophagogastric junction carcinoma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| adebrelimab combined with chemotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adebrelimab,Paclitaxel,Lobaplatin,Fluorouracil | Drug | adebrelimab: 1200mg,D1,q3w; Paclitaxel: 50mg/m2 D1/8/15; Lobaplatin: 50mg,iv 2h,d1; Fluorouracil: 400mg/m2,bolus iv,600mg/m2,iv 22h,d1-3; |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological Complete Response (pCR) | defined as the absence of any viable tumor at the time of surgical resection, as assessed by central and local pathology laboratory | At time of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| R0 resection rate | R0 resection rate | At time of surgery |
| Disease-Free Survival (DFS) | Time after R0 resection to disease recurrence or death Time after R0 resection to disease recurrence or death Time after R0 resection to disease recurrence or death Time after R0 resection to disease recurrence or death |
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Inclusion Criteria:
1) Hemoglobin ≥ 90 g/L; 2) Leukocytes ≥ 3.0x10^9/L; Absolute neutrophil count≥ 1.5x10^9/L; 3) Platelet ≥ 100x10^9/L; 4) Serum creatinine ≤1.5 ULN or creatinine clearance rate≥50 mL/min; 5) Total bilirubin ≤1.5 ULN; 6) ALT ≤2.5 ULN; AST ≤2.5 ULN; 7) Urinary protein <2+; if urine protein≥2+, 24-hour urine protein quantification shows that the protein must be ≤1g; 7. Coagulation function test:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liu Hong, MD,PhD | Contact | 13709284513 | hongliu180@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital, the Air Force Medical University | Xi'an | Shaan'xi | 710032 | China |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| up to 2 year |
| Overall Survival (OS) | defined as the time from randomization to death from any cause during the course of the study. | up to 2 year |
| Number of participants with treatment-related adverse events | assessed by CTCAE v4.03 | 6 months |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |