Esophageal Carcinoma
Conditions
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.
Interventions
BIOLOGICALcamrelizumab
Subjects receive camrelizumab intravenous infusion at the dose 200mg on Day 1 every 2 weeks
DRUGDocetaxel
Subjects receive Docetaxel intravenous infusion at the dose 75mg/m2 on Day 1 every 3 weeks
DRUGIrinotecan
Subjects receive Irinotecan intravenous infusion at the dose 180mg/m2 on Day 1 every 2 weeks
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) | approximately 24 months |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Camrelizumab camrelizumab: Subjects received camrelizumab intravenous infusion at the dose 200mg on Day 1 every 2 weeks | 228 |
| Investigator's Choice of Standard Therapy Docetaxel or Irinotecan
Docetaxel: Subjects received Docetaxel intravenous infusion at the dose 75mg/m2 on Day 1 every 3 weeks
Irinotecan: Subjects received Irinotecan intravenous infusion at the dose 180mg/m2 on Day 1 every 2 weeks | 220 |
| Total | 448 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 2 | 3 |
Baseline characteristics
| Characteristic | Camrelizumab | Total | Investigator's Choice of Standard Therapy |
|---|---|---|---|
| Age, Continuous | 59.3 years STANDARD_DEVIATION 7.46 | 59.4 years STANDARD_DEVIATION 7.08 | 59.5 years STANDARD_DEVIATION 6.68 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 228 Participants | 448 Participants | 220 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment China | 228 participants | 448 participants | 220 participants |
| Sex: Female, Male Female | 20 Participants | 48 Participants | 28 Participants |
| Sex: Female, Male Male | 208 Participants | 400 Participants | 192 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 23 / 228 | 10 / 220 |
| other Total, other adverse events | 226 / 228 | 210 / 220 |
| serious Total, serious adverse events | 71 / 228 | 52 / 220 |
Outcome results
Primary
Overall Survival (OS)
Time frame: approximately 24 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Camrelizumab | Overall Survival (OS) | 8.28 months |
| Investigator's Choice of Standard Therapy | Overall Survival (OS) | 6.24 months |