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| Name | Class |
|---|---|
| The People's Hospital of Gaozhou | OTHER |
| The General Hospital of Southern Theater Command | OTHER |
| Affiliated Cancer Hospital & Institute of Guangzhou Medical University | OTHER |
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The role of preoperative chemotherapy as standard therapy is well-established for advanced esophageal cancer. Immunotherapeutic agents such as Immune checkpoint inhibitors has been shown to improve objective response rate in solid tumors. However, there is a paucity of data regarding the efficacy and safety of preoperative immunotherapy plus chemotherapy in esophageal cancer patients in real-world practice. This study set out to investigate whether the combination of preoperative chemotherapy and immune checkpoint inhibitors is beneficial to improve the objective response rate as well as the pathological complete response rate in a real-world scenario.
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| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Objective Response Rate | Up to 24 weeks |
| Safety as measured by number of participants with Grade 3 and 4 adverse events | Number of Grade 3 and 4 adverse events as defined by CTCAE v5.0 | Up to 12 weeks |
| Feasibility of immunochemotherapy defined as at least 80% of the patients completed all planned courses | The feasibility of immunochemotherapy was defined as at least 80% of the patients completed all planned courses. | Up to 36 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic complete response rate (pCR) | The rate of pathologic complete response rate after the combined treatment of chemotherapy and immunotherapy following surgery | Three to five working days after surgery |
| R0 resection rate |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed as potentially resectable (including initially-unresectable) esophageal squamous cell carcinoma via pathological specimen, KPS ≥ 80, has adequate organ function and no distant metastasis are included in the study
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| Name | Affiliation | Role |
|---|---|---|
| Guibin Qiao, MD | Guangdong Provincial People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial People's Hospital | Guangzhou | Guangdong | 510080 | China | ||
| Shantou Central Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40146232 | Derived | Yang W, Ma SC, Fang Z, Liu Y, Zhang X, Wang F, Wang C, Wang Y, Wang X, Chen W, Luo H, Yang L, Zhang S, Zeng B, Liu Z, Ou Q, Cai J, Yeung SJ, Cheng C. TP53-centric ctDNA complements PET/CT for non-invasive assessment of pathological complete response and survival after neoadjuvant immunochemotherapy in esophageal squamous cell carcinoma: a prospective cohort study. Int J Surg. 2025 May 1;111(5):3256-3268. doi: 10.1097/JS9.0000000000002341. |
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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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| First Affiliated Hospital of Shantou University Medical College |
| OTHER |
| First Affiliated Hospital, Sun Yat-Sen University | OTHER |
| Shantou Central Hospital | OTHER |
| Shenzhen People's Hospital | OTHER |
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The R0 resection rate of esophagectomy
| Three to five working days after surgery |
| Overall survival | Overall survival rate | from the date of diagnosis to the date of death, assessed up to 100 months |
| Event-free survival | EFS | from the date of treatment initiation to the date of first progression (local recurrence of tumor or distant metastasis) or death from any cause, assessed up to 100 months |
| Major pathological response | ≤10% residual viable tumor follow NAIC | Three to five working days after surgery |
| Shantou |
| Guangdong |
| 515031 |
| China |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |