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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03222440
Recruitment Status : Completed
First Posted : July 19, 2017
Last Update Posted : December 4, 2019
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
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
Actual Study Start Date : July 19, 2017
Actual Primary Completion Date : July 20, 2018
Actual Study Completion Date : November 1, 2019

Resource links provided by the National Library of Medicine

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, one cycle is four weeks, total 8 cycles ) 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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 identifier (NCT number): NCT03222440

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China, Tianjin
Department of Radiation Oncology, Tianjin Medical University Cancer Hospital
Tianjin, Tianjin, China, 300060
Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
Jiangsu HengRui Medicine Co., Ltd.
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Principal Investigator: PING WANG, MD.PHD Tianjin Medical University Institute and Hospital
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Responsible Party: Tianjin Medical University Cancer Institute and Hospital Identifier: NCT03222440    
Other Study ID Numbers: SHR-1210-RT-ESC-IIT
First Posted: July 19, 2017    Key Record Dates
Last Update Posted: December 4, 2019
Last Verified: November 2019

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