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| Name | Class |
|---|---|
| Military 301 Hospital | UNKNOWN |
| Peking University Cancer Hospital & Institute | OTHER |
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | OTHER |
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Our previous study, a single-center, prospective, single-arm Phase II study (Keypoint001) has demonstrated the efficacy and safety of neoadjuvant chemotherapy combined with immunotherapy in locally advanced (cT3-4N+M0) esophageal squamous cell carcinoma. The results show that the pathological complete response rate (pCR) reaches 35%, and the major pathological response rate is over 70%, which is much higher than that of patients receiving chemotherapy alone. Meanwhile, no severe adverse drug reactions have been found in terms of safety, so this treatment regimen is safe and reliable.
However, the cycle of neoadjuvant immunotherapy is still under exploration. Currently, the mainstream research centers adopt a regimen of 2 to 4 cycles. The exploration results of our center have found that most patients' conditions can be further alleviated after 4 cycles compared with after 2 cycles, but there are still a small number of patients with no obvious remission. Therefore, we consider observing whether patients with no obvious remission can achieve a better pathological response rate through further radiotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 cycles chemoimmunotherapy plus surgery | Experimental | 2 cycles chemoimmunotherapy and surgery |
|
| 4 cycles chemoimmunotherapy plus surgery | Experimental | 4 cycles chemoimmunotherapy and surgery |
|
| 4 cycles chemoimmunotherapy plus radiotherapy and surgery | Experimental | 4 cycles chemoimmunotherapy plus radiotherapy and surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chemotherapy | Drug | carboplatin plus nab-paclitaxel |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathological response | Postoperative pathology according to CAP classification. | After surgery |
| 2-year and 5-year overall survival | overall survival after 2 years and 5 years | 2 years and 5 years after therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse effect incidence | Adverse effect according to CTCAE and RTOG criteria | 1 years after therapy |
| R0 resection rate | After surgery | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Li | Contact | +86-10-69152630 | Lili4037@pumch.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100730 | China |
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| ID | Term |
|---|---|
| D000077277 | Esophageal Squamous Cell Carcinoma |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D007167 | Immunotherapy |
| C582435 | pembrolizumab |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
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| Immunotherapy (Pembrolizumab) | Drug | Pembrolizumab |
|
| radiotherapy | Radiation | 40-45Gy/20fx,5 times a week |
|
| postoperative complications |
postoperative complications according to Clavien-Dindo classification |
| After surgery |
| 2-year and 5-year disease-free survival | disease-free survival after 2 years and 5 years | 2 years and 5 years after therapy |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |