Phase 3
N=448
Study of SHR-1210 Versus Investigator's Choice of Chemotherapy for Participants With Advanced Esophageal Cancer
Esophageal Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT03099382 ↗Enrolled (actual)
448
Serious AEs
27.5%
Results posted
Jan 2024
Primary outcome: Primary: Overall Survival (OS) — 8.28; 6.24 months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- camrelizumab (Biological); Docetaxel (Drug); Irinotecan (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) |
8.28; 6.24 | — |
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.
Eligibility Criteria
Inclusion Criteria
- age: 18-75 years, male or female.
- Histologically or cytologically confirmed Squamous Cell Carcinoma of the Esophagus, locally advanced, unresectable disease, recurrent or Metastatic disease.
- Fail to the first-line standard therapy.
- Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
- Can provide either a newly obtained or archival tumor tissue sample.
- ECOG 0-1.
- Life expectancy of greater than 12 weeks.
- Adequate organ function.
- 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.
- Patient has given written informed consent.
Exclusion Criteria
- 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.
- Known central nervous system (CNS) metastases.
- Subjects with any active autoimmune disease or history of autoimmune disease.
- 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;
- 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);
- History of Interstitial Pneumonia or received Corticosteroids for non-infectious pneumonitis.
- Known Human Immunodeficiency Virus (HIV) infection, active Hepatitis B or Hepatitis C.
- BMI, 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.
- 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.
- Currently participating or has participated in a study within 4 weeks of the first dose of study medication.
- Received a live vaccine within 4 weeks of the first dose of study medication.
- Pregnancy or breast feeding.
- According to the investigator, other conditions that may lead to stop the research.
Data sourced from ClinicalTrials.gov (NCT03099382). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.