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

• ClinicalTrials.gov Identifier: NCT03099382
• Recruitment Status: Completed
• First Posted: April 4, 2017
• Results First Posted: January 22, 2024
• Last Update Posted: January 22, 2024
• Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Information provided by (Responsible Party): Jiangsu HengRui Medicine Co., Ltd.

Study Description

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: camrelizumab; Drug: Docetaxel; Drug: Irinotecan	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 457 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized, Open-Label, Active-Controlled, Multi-Center, Phase III Clinical Study of Anti-PD-1 Antibody SHR-1210 vs. Investigator's Choice of Chemotherapy in Subjects With Locally Advanced or Metastatic Esophageal Cancer
• Actual Study Start Date: May 5, 2017
• Actual Primary Completion Date: May 6, 2019
• Actual Study Completion Date: May 6, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: camrelizumab	Biological: camrelizumab; Subjects receive camrelizumab intravenous infusion at the dose 200mg on Day 1 every 2 weeks; Other Name: SHR-1210
Active Comparator: Investigator's Choice of Standard Therapy; Docetaxel or Irinotecan	Drug: Docetaxel; Subjects receive Docetaxel intravenous infusion at the dose 75mg/m2 on Day 1 every 3 weeks; Drug: Irinotecan; Subjects receive Irinotecan intravenous infusion at the dose 180mg/m2 on Day 1 every 2 weeks

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• 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 female.
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% weight 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 treatment. Except: inhalation or topical corticosteroids. Doses > 10 mg/day prednisone or equivalent 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.

Contacts and Locations

Locations

China, Beijing

307 Hospital of PLA

Beijing, Beijing, China

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing, China

Sponsors and Collaborators

Jiangsu HengRui Medicine Co., Ltd.

  Study Documents (Full-Text)

Documents provided by Jiangsu HengRui Medicine Co., Ltd.:

Study Protocol  [PDF] April 12, 2018

Statistical Analysis Plan  [PDF] June 28, 2017

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
• ClinicalTrials.gov Identifier: NCT03099382
• Other Study ID Numbers: SHR-1210-III-301-ESC
• First Posted: April 4, 2017
• Results First Posted: January 22, 2024
• Last Update Posted: January 22, 2024
• Last Verified: April 2023

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

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; Topoisomerase I Inhibitors; Topoisomerase Inhibitors; Enzyme Inhibitors