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Neoadjuvant Anti-PD-1 Antibody SHR-1210 and Radiation in Resectable Esophageal Squamous Cell Carcinoma

NCT03200691 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2017-08-07

No results posted yet for this study

Summary

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

Conditions

  • Esophageal Neoplasms
  • Esophageal Diseases

Interventions

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.

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    collaborator INDUSTRY

  • Hangzhou Cancer Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-10
Primary Completion
2018-06-30
Completion
2020-07-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03200691 on ClinicalTrials.gov