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Completed

NCT Number: NCT03222440

Combination of Radiotherapy and SHR-1210 to Treat Patients With ESCC

SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody. This is an open-label,single center ,non-randomized ,Single Arm Exploratory Study . This clinical study is an investigator-initiatedclini-cal trial(IIT ).The objective of this study is to evaluate the efficacy and safety of radiation therapy combined with anti-PD-1 antibody SHR-1210 in patients with Locally Advanced Esophageal Squamous Cell Carcinomas。

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Radiation Oncology, Tianjin Medical University Cancer Hospital

Tianjin, Tianjin Municipality, 300060, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age:18-75 years, male or femal.
  • Histologically confirmed primary Squamous Cell Carcinoma of the Esophagus,Local advanced esophageal cancer diagnosed by pathology and imaging,clinical stage T3-4N0M0, T1-4N+M0,Ⅱ-Ⅳa.
  • Pre-treatment evaluation can not tolerate concurrent radiochemotherapy or rejection of the concurrent use of chemotherapy with radiotherapy.
  • Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
  • ECOG 0-1.
  • Adequate organ function.
  • Life expectancy of greater than 6 months.
  • Patient has given written informed consent.

Exclusion criteria

  • Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy.
  • Known history of hypersensitivity to macromolecular protein preparation or any components of the SHR- 1210 formulation.
  • Subjects before or at the same time with other malignant tumors (except which has cured skin basal cell carcinoma and cervical carcinoma in situ);
  • Subjects with any active autoimmune disease or history of autoimmune disease
  • Uncontrolled clinically significant heart disease, including but not limited to the following: (1) > NYHA II congestive heart failure; (2) unstable angina, (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention;
  • Active infection or an unexplained fever > 38.5°C during screening or before the first scheduled day of dosing (subjects with tumor fever may be enrolled at the discretion of the investigator);
  • Received a live vaccine within 4 weeks of the first dose of study medication.
  • Pregnancy or breast feeding.
  • Decision of unsuitableness by principal investigator or physician-in-charge.

Treatment and study plan

SHR-1210

Drug

SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody.

Other names: Anti-PD-1 Antibody

Primary outcomes

  1. Incidence of Treatment-Emergent Adverse Events

    Time frame: Through study completion, an average of half a year

    Adverse events (AE), Serious Adverse Event(SAE)

Secondary outcomes

  1. ORR

    Time frame: Through study completion, an average of 1 year

    Objective Response Rate

  2. PFS

    Time frame: 1year and 3years

    Progression-Free Survial

  3. OS

    Time frame: 1year and 3years

    Overall Survival

Sponsors and collaborators

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital

Other

Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

Registry information

Official study title

A Single Arm Exploratory Study of Radiation Therapy With Anti-PD-1 Antibody SHR-1210 in Treating Patients With Locally Advanced Esophageal Squamous Cell Carcinomas

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jul 19, 2017
Registry last updated
Dec 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.