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Study of SHR-1210 Versus Investigator's Choice Standard Therapy for Participants With Advanced Esophageal Cancer

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.
 
ClinicalTrials.gov Identifier: NCT03099382
Recruitment Status : Completed
First Posted : April 4, 2017
Last Update Posted : October 25, 2019
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Tracking Information
First Submitted Date  ICMJE March 28, 2017
First Posted Date  ICMJE April 4, 2017
Last Update Posted Date October 25, 2019
Actual Study Start Date  ICMJE May 10, 2017
Actual Primary Completion Date May 6, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2017)
Overall Survival (OS) [ Time Frame: approximately 24 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of SHR-1210 Versus Investigator's Choice Standard Therapy for Participants With Advanced Esophageal Cancer
Official Title  ICMJE A Phase III Randomized Open-Label Study of Single Agent SHR-1210 vs Investigator's Choice Standard Therapy in Subjects With Advanced/Metastatic Esophageal Cancer
Brief Summary In this study, participants with advanced or metastatic squamous cell carcinoma of the esophagus that has progressed after first-line standard therapy will be randomized to receive either single agent SHR-1210 or the Investigator's choice of standard therapy with docetaxel or irinotecan. The primary study hypothesis is that treatment with SHR-1210 will prolong overall survival (OS) as compared to treatment with standard therapy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Esophageal Carcinoma
Intervention  ICMJE
  • Biological: SHR-1210
    Subjects receive SHR-1210 intravenous at the dose 200mg on Day 1 every 2 weeks
  • Drug: Docetaxel
    Subjects receive Docetaxel intravenous at the dose 75mg/m2 on Day 1 every 3 weeks
  • Drug: Irinotecan
    Subjects receive Irinotecan intravenous at the dose 180mg/m2 on Day 1 every 2 weeks
Study Arms  ICMJE
  • Experimental: SHR-1210
    Intervention: Biological: SHR-1210
  • Active Comparator: Investigator's Choice Standard Therapy
    Docetaxel or Irinotecan
    Interventions:
    • Drug: Docetaxel
    • Drug: Irinotecan
Publications * Huang J, Xu J, Chen Y, Zhuang W, Zhang Y, Chen Z, Chen J, Zhang H, Niu Z, Fan Q, Lin L, Gu K, Liu Y, Ba Y, Miao Z, Jiang X, Zeng M, Chen J, Fu Z, Gan L, Wang J, Zhan X, Liu T, Li Z, Shen L, Shu Y, Zhang T, Yang Q, Zou J; ESCORT Study Group. Camrelizumab versus investigator's choice of chemotherapy as second-line therapy for advanced or metastatic oesophageal squamous cell carcinoma (ESCORT): a multicentre, randomised, open-label, phase 3 study. Lancet Oncol. 2020 Jun;21(6):832-842. doi: 10.1016/S1470-2045(20)30110-8. Epub 2020 May 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 23, 2019)
457
Original Estimated Enrollment  ICMJE
 (submitted: March 28, 2017)
438
Actual Study Completion Date  ICMJE May 6, 2019
Actual Primary Completion Date May 6, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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,recurrent or Metastatic disease.
  3. Fail to the first-line standard therapy.
  4. Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
  5. Can provide either a newly obtained or archival tumor tissue sample.
  6. ECOG 0-1.
  7. Life expectancy of greater than 12 weeks.
  8. Adequate organ function.
  9. 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 or through 180 days after the last dose of docetaxel or irinotecan.
  10. Patient has given written informed consent.

Exclusion Criteria:

  1. Has a known additional malignancy within the last 5 years before study treatment with the exception of curatively treated basal cell and squamous cell carcinoma of the skin and/or curatively resected in-situ cervical and/or breast cancers.
  2. Known central nervous system (CNS) metastases.
  3. Subjects with any active autoimmune disease or history of autoimmune disease.
  4. 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;
  5. Active infection or an unexplained fever > 38.5°C before two weeks of randomization (subjects with tumor fever may be enrolled at the discretion of the investigator);
  6. History of Interstitial Pneumonia or received Corticosteroids for non-infectious pneumonitis.
  7. Known Human Immunodeficiency Virus (HIV) infection、active Hepatitis B or Hepatitis C.
  8. BMI,<18.5mg/m2 or ≥10% weigth lost before screening.
  9. Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) agent.
  10. Known history of hypersensitivity to macromolecular protein preparation or any components of the SHR-1210 formulation, allergy, hypersensitivity, or contraindication to docetaxel, or irinotecan.
  11. 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.
  12. 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.
  13. Currently participating or has participated in a study within 4 weeks of the first dose of study medication.
  14. Received a live vaccine within 4 weeks of the first dose of study medication.
  15. Pregnancy or breast feeding.
  16. According to the investigator, other conditions that may lead to stop the research.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03099382
Other Study ID Numbers  ICMJE SHR-1210-III-301-ESC
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jiangsu HengRui Medicine Co., Ltd.
Study Sponsor  ICMJE Jiangsu HengRui Medicine Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Jiangsu HengRui Medicine Co., Ltd.
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP