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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|