Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Jiangsu HengRui Medicine Co., Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The objective of this study is to evaluate the efficacy and safety of radiation therapy combined with anti-PD-1 antibody SHR-1210 followed by surgery in treating patients with resectable esophageal squamous cell carcinoma
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nimotuzumab with radiotherapy | Experimental | Patients will receive neoadjuvant radiotherapy with concurrent anti-PD-1 antibody SHR-1210. Radiation of primary tumor and local lymph nodes with 95% planning target volume (PTV) of 40Gy/20f. SHR-1210 200mg fixed dose every 2 weeks delivered concurrent with radiation therapy. After 2-4 weeks of neoadjuvant treatment, patients will be evaluated by a multidisciplinary teams (MDTs) and esophagectomy will be given for patients with resectable disease. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3-DCRT or IMRT radiation | Radiation | Radiation of primary tumor and local lymph nodes with 95% planning target volume (PTV) of 40 Gy/20f. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic Complete Response Rate | the Percentage of Patients Who Have No Evidence of Cancer in Their Surgical Specimen Following Surgery | 2-4 weeks after completion of radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-Free Survival | Defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death from any cause. | 2 years |
| Numbers of adverse events and the degree of each adverse events according to the NCI CTCAE 4.0 criteria. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| shixiu wu, MD | Contact | +8657186826086 | wushixiu@medmail.com.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hangzhou Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310002 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D004935 | Esophageal Diseases |
| D000077277 | Esophageal Squamous Cell Carcinoma |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| anti-PD-1 antibody SHR-1210 | Drug | SHR-1210 (200mg fixed dose every 2 weeks for 2 cycles) will be administered as an intravenous infusion over 60 minutes. |
|
From the date of randomization to 6 months after esophagectomy. An expected average of 6 months |
| 6 months |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018307 | Neoplasms, Squamous Cell |