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

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ClinicalTrials.gov Identifier: NCT03099382
Recruitment Status : Recruiting
First Posted : April 4, 2017
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Esophageal Carcinoma Biological: SHR-1210 Drug: Docetaxel Drug: Irinotecan Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 438 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 10, 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SHR-1210 Biological: SHR-1210
Subjects receive SHR-1210 intravenous at the dose 200mg on Day 1 every 2 weeks

Active Comparator: Investigator's Choice Standard Therapy
Docetaxel or Irinotecan
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




Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: approximately 24 months ]


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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,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.

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): NCT03099382


Contacts
Contact: qing yang, MD 86-21-68868570 ext 836 yangqing@hrs.com.cn

Locations
China
307 Hospital of PLA Recruiting
Beijing, China
Contact: jianming xu, PHD       jmxu2003@yahoo.com   
Cancer Hospital Chinese Academy of Medical Sciences Recruiting
Beijing, China
Contact: jing huang, PHD       huangjingwg@163.com   
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.

Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT03099382     History of Changes
Other Study ID Numbers: SHR-1210-III-301-ESC
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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
Docetaxel
Irinotecan
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors