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

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

Tracking Information

• First Submitted Date: March 28, 2017
• First Posted Date: April 4, 2017
• Last Update Posted Date: October 25, 2019
• Actual Study Start Date: May 10, 2017
• Actual Primary Completion Date: May 6, 2019 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 28, 2017): Overall Survival (OS) [ Time Frame: approximately 24 months ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study of SHR-1210 Versus Investigator's Choice Standard Therapy for Participants With Advanced Esophageal Cancer
• 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
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Esophageal Carcinoma

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 23, 2019): 457
• Original Estimated Enrollment (submitted: March 28, 2017): 438
• Actual Study Completion Date: May 6, 2019
• Actual Primary Completion Date: May 6, 2019 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT03099382
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
• Study Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Jiangsu HengRui Medicine Co., Ltd.
• Verification Date: October 2019