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Esophageal cancer is the most prevalent cancer globally with poor survival outcome. The prognosis with surgery alone is poor, accounting for 30-40% of overall survival at 5 year. Either neoadjuvant chemotherapy (nCT) or chemoradiotherapy (nCRT) has been shown as efficatious therapy to improve patients outcomes in esophageal or esophagogastric junction cancer as compared with surgery alone. The purpose of this study was to explore the optimal neoadjuvant treatment modalities including PD-1/PD-L1 antibody or targeted drug for patients with esophageal or esophagogastric junction cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (Neoadjuvant chemotherapy) nCT | Experimental | This arm received chemotherapy with or without immunotherapy/targeting agents as neoadjuvant treatment. |
|
| (Neoadjuvant Chemoradiation) nCRT | Placebo Comparator | This arm received chemoradiotherapy with or without immunotherapy/targeting agents as neoadjuvant treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platinum based chemotherapy | Drug | q1-3W according to physician's preference |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 5 year |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | 1 year, 2 year, 3 year, 5 year | |
| Number of participants with Acute and late toxicities of radiotherapy,chemotherapy and immunotherapy | Acute and late toxicities are evaluated by NCI-CTC version 5.0 |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of the correlation between radiation dose and the number of participants with treatment-related adverse events as assessed by CTCAE v4.0. | 1 year, 2 year, 3 year, 5 year | |
| Radiomics analysis | The value of Radiomics of MRI and CT in predicting pathological complete response (pCR) or no response (NR) and the correlation between radiomics of MRI and CT and overall survival (OS), which is defined as the time from the beginning of neoadjuvant chemotherapy to the death with any causes. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin Wang, MD | Contact | +861013311583220 | beryl_wx2000@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC) | Recruiting | Beijing | 100021 |
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| Paclitaxel based chemotherapy | Drug | q1-3W according to physician's preference |
|
| Radiotherpay | Radiation | 40-50Gy/1.8-2.2Gy/20-25f |
|
| Surgery | Procedure | Radical esophagectomy |
|
| Immunotherapy | Drug | Anti-PD-1/PD-L1 Antibody |
|
| 5-FU Analog based chemotherpay | Drug | W1-5 qW or d1-14, q3W according to physician's preference |
|
| Nimotuzumab | Drug | 200-400mg, d1,qW |
|
| 3 months |
| Pathological response rate | Pathological response were classified into three grades.Grade I signifies that there is little shrinkage in the tumor; only mild regression in the tumor cells is observed under themicroscope. Grade II shows gross reduction in size of the tumor and marked regression in the cancer cells microscopically, yet viable nests of cancer tissue are still visible. Grade III implies complete or almost total resolution of the tumor on exploration, and disappearance of the tumor tissue microscopically; only remnants of degenerated cancer cells can be seen (so-called ghost cancer cells). | 3 months |
| R0 resection rate | 3 months |
| Locoregional recurrence free survival | 1 year, 2 year, 3 year, 5 year |
| Distant metastasis free survival | 1 year, 2 year, 3 year, 5 year |
| 1 year, 2 year, 3 year, 5 year |
| Target dealineation of organs at risk and their impact on the prognosis and adverse effects of radiotherapy | 1 year, 2 year, 3 year, 5 year |
| Target dealineation of clinical target volumn and their impact on the prognosis | 1 year, 2 year, 3 year, 5 year |
| China |
|
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D017671 | Platinum Compounds |
| D013514 | Surgical Procedures, Operative |
| D007167 | Immunotherapy |
| C501466 | nimotuzumab |
| ID | Term |
|---|---|
| D007287 | Inorganic Chemicals |
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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