Neoadjuvant Anti-PD-1 Antibody SHR-1210 and Radiation in Resectable Esophageal Squamous Cell Carcinoma
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|ClinicalTrials.gov Identifier: NCT03200691|
Recruitment Status : Recruiting
First Posted : June 27, 2017
Last Update Posted : August 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Neoplasms Esophageal Diseases||Radiation: 3-DCRT or IMRT radiation Drug: anti-PD-1 antibody SHR-1210||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Neoadjuvant Anti-PD-1 Antibody SHR-1210 and Radiation in Resectable Esophageal Squamous Cell Carcinoma|
|Estimated Study Start Date :||August 10, 2017|
|Estimated Primary Completion Date :||June 30, 2018|
|Estimated Study Completion Date :||July 1, 2020|
Experimental: Nimotuzumab with radiotherapy
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.
Radiation: 3-DCRT or IMRT radiation
Radiation of primary tumor and local lymph nodes with 95% planning target volume (PTV) of 40 Gy/20f.
Drug: anti-PD-1 antibody SHR-1210
SHR-1210 (200mg fixed dose every 2 weeks for 2 cycles) will be administered as an intravenous infusion over 60 minutes.
- Pathologic Complete Response Rate [ Time Frame: 2-4 weeks after completion of radiotherapy ]the Percentage of Patients Who Have No Evidence of Cancer in Their Surgical Specimen Following Surgery
- Disease-Free Survival [ Time Frame: 2 years ]Defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death from any cause.
- Numbers of adverse events and the degree of each adverse events according to the NCI CTCAE 4.0 criteria. [ Time Frame: 6 months ]From the date of randomization to 6 months after esophagectomy. An expected average of 6 months
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03200691
|Contact: shixiu wu, MDemail@example.com|
|Hangzhou Cancer Hospital||Recruiting|
|Hangzhou, Zhejiang, China, 310002|
|Contact: Shixiu Wu, MD +8657186826086 firstname.lastname@example.org|