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Combination of Radiation Therapy and Anti-PD-1 Antibody SHR-1210 in Treating Patients With Esophageal Cancer

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ClinicalTrials.gov Identifier: NCT03187314
Recruitment Status : Recruiting
First Posted : June 14, 2017
Last Update Posted : August 7, 2017
Sponsor:
Collaborator:
Jiangsu HengRui Medicine Co., Ltd.
Information provided by (Responsible Party):
Shixiu Wu, Hangzhou Cancer Hospital

Brief Summary:
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 esophageal cancer

Condition or disease Intervention/treatment Phase
Esophageal Neoplasms Esophageal Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Drug: Radiation Drug: SHR-1210 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Radiation Therapy With Anti-PD-1 Antibody SHR-1210 in Treating Patients With Unresectable Esophageal Cancer
Actual Study Start Date : June 14, 2017
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental Group
Radiation to 60 Gy, 5 x 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 5 cycles) will be administered as an intravenous infusion over 60 minutes.
Drug: Radiation
RT to 60 Gy, 5 x per week,for 6 weeks. Radiation begun the day after the first dose of SHR-1210

Drug: SHR-1210
SHR-1210 (200mg fixed dose every 2 weeks for 5 cycles) will be administered as an intravenous infusion over 60 minutes.




Primary Outcome Measures :
  1. Local control [ Time Frame: two years after enrollment ]
    occurrence of local or regional progression


Secondary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [ Time Frame: 3 months ]
    Number of participants with treatment-related adverse events as assessed by Number of participants with treatment-related adverse events as assessed by treatment-related adverse events assessed by CTCAE v4.0

  2. Objective response rate [ Time Frame: 3 months ]
    Objective response rate as assessed by RECIST criteria

  3. Overall survival [ Time Frame: 1 year ]
    Overall survival



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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
Criteria

Inclusion Criteria:

  1. age:18-75 years, male or femal.
  2. Histologically or cytologically confirmed Squamous Cell Carcinoma of the Esophagus, locally advanced, unresectable disease.
  3. Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
  4. Can provide either a newly obtained or archival tumor tissue sample.
  5. ECOG 0-1.
  6. Life expectancy of greater than 12 weeks.
  7. Adequate organ function.
  8. Female: child bearing potential, a negative urine or serum pregnancy test result within 72 h before study treatment. Participants of reproductive potential must be willing to use adequate contraception for the course of the study through 3 months after the last dose of SHR-1210.
  9. 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. Complete obstruction of the esophagus, or patients who have the potential to develop perforation
  3. Other malignancy within 5 years prior to entry into the study, expect for curatively treated basal cell and squamous cell carcinoma of the skin and/or curatively resected in-situ cervical and/or breast cancers.
  4. Known central nervous system (CNS) metastases.
  5. Subjects with any active autoimmune disease or history of autoimmune disease.
  6. 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;
  7. 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);
  8. History of Interstitial Pneumonia or active non-infectious pneumonitis.
  9. Known Human Immunodeficiency Virus (HIV) infection、active Hepatitis B or Hepatitis C.
  10. Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) agent.
  11. Known history of hypersensitivity to macromolecular protein preparation or any components of the SHR-1210 formulation.
  12. Concurrent medical condition requiring the use of cortisol (>10mg/day Prednisone or equivalent dose) or other systematic immunosuppressive medications within 14 days before the study treament. Except: inhalation or topical corticosteroids. Doses > 10 mg/day prednisone or equivalen for replacement therapy.
  13. Has received prior anti-cancer monoclonal antibody (mAb), chemotherapy, targeted small molecule therapy, or radiation therapy within 4 weeks prior to study Day 1 or not recovered from adverse events due to a previously administered agent.
  14. Received a live vaccine within 4 weeks of the first dose of study medication.
  15. Pregnancy or breast feeding.
  16. Decision of unsuitableness by principal investigator or physician-in-charge.

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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): NCT03187314


Locations
China, Zhejiang
Hangzhou Cancer Hospital Recruiting
Hangzhou, Zhejiang, China, 310002
Contact: Shixiu Wu, MD    +8657186826086    wushixiu@medmail.com.cn   
Sponsors and Collaborators
Hangzhou Cancer Hospital
Jiangsu HengRui Medicine Co., Ltd.

Responsible Party: Shixiu Wu, Professor, Hangzhou Cancer Hospital
ClinicalTrials.gov Identifier: NCT03187314     History of Changes
Other Study ID Numbers: HangzhouCH08
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: August 7, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by Shixiu Wu, Hangzhou Cancer Hospital:
Esophageal cancer
Radiation
Anti-PD-1 Antibody

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