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

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ClinicalTrials.gov Identifier: NCT03222440
Recruitment Status : Recruiting
First Posted : July 19, 2017
Last Update Posted : July 19, 2017
Sponsor:
Collaborator:
Jiangsu HengRui Medicine Co., Ltd.
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital

Brief Summary:
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。

Condition or disease Intervention/treatment Phase
Esophageal Cancer Drug: SHR-1210 Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Estimated Study Start Date : July 20, 2017
Estimated Primary Completion Date : July 20, 2018
Estimated Study Completion Date : July 20, 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: SHR-1210+ Radiotherapy
Radiotherapy,intensity modulated radiation therapy (IMRT), 54-60 Gy, 1.8-2.0 Gy per fraction ,5 fractions per week, for 6 weeks. Radiation begun the day after the first dose of SHR-1210. SHR-1210 (200mg fixed dose every 2 weeks for 9 cycles,one cycle is two weeks ) will be administered as an intravenous infusion over 30 minutes.
Drug: SHR-1210
SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody.
Other Name: Anti-PD-1 Antibody



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. age:18-75 years, male or femal.
  2. 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.
  3. Pre-treatment evaluation can not tolerate concurrent radiochemotherapy or rejection of the concurrent use of chemotherapy with radiotherapy.
  4. Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
  5. ECOG 0-1.
  6. Adequate organ function.
  7. Life expectancy of greater than 6 months.
  8. Patient has given written informed consent.

Exclusion Criteria:

  1. Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy.
  2. Known history of hypersensitivity to macromolecular protein preparation or any components of the SHR- 1210 formulation.
  3. Subjects before or at the same time with other malignant tumors (except which has cured skin basal cell carcinoma and cervical carcinoma in situ);
  4. Subjects with any active autoimmune disease or history of autoimmune disease
  5. 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;
  6. 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);
  7. Received a live vaccine within 4 weeks of the first dose of study medication.
  8. Pregnancy or breast feeding.
  9. Decision of unsuitableness by principal investigator or physician-in-charge.

Information from the National Library of Medicine

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): NCT03222440


Contacts
Contact: PING WANG, MD.PHD 13032215357 wangping@tjmuch.com

Locations
China, Tianjin
Department of Radiation Oncology, Tianjin Medical University Cancer Hospital Recruiting
Tianjin, Tianjin, China, 300060
Contact: Ping Wang, M. D.    08623340123-1141    wangping@tjmuch.com   
Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
Jiangsu HengRui Medicine Co., Ltd.
Investigators
Principal Investigator: PING WANG, MD.PHD Tianjin Medical University Institute and Hospital

Responsible Party: Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier: NCT03222440     History of Changes
Other Study ID Numbers: SHR-1210-RT-ESC-IIT
First Posted: July 19, 2017    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs