A Phase II Clinical Trial of Anti-PD-1 Antibody SHR-1210 Versus Placebo as Consolidation Chemotherapy After Radical Concurrent Chemoradiotherapy in Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma
Overview
- Phase
- Phase 2
- Intervention
- SHR-1210
- Conditions
- Esophageal Squamous Cell Carcinoma
- Sponsor
- The First Affiliated Hospital of Zhengzhou University
- Enrollment
- 725
- Locations
- 1
- Primary Endpoint
- PFS
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study is to observe and evaluate the efficacy and safety of SHR-1210 vs placebo as consolidation chemotherapy after radical concurrent chemoradiotherapy for unresectable locally advanced ESCC.
Detailed Description
In China, the incidence of esophageal cancer has declined in recent years, but the mortality rate has been ranked fourth. Morbidity and mortality were ranked sixth and fourth in all malignancies, respectively. Therefore, esophageal cancer has always been a major malignant tumor that threatens the health of our residents. We designed a multicenter, randomized, double-blind, open-label phase II clinical trial of anti-PD-1 antibody SHR-1210 versus placebo as consolidation chemotherapy (CCT) after radical concurrent chemoradiotherapy for unresectable locally advanced esophageal squamous cell carcinoma (ESCC).The purpose of this study is to observe and evaluate the efficacy and safety of SHR-1210 vs placebo as consolidation chemotherapy after radical concurrent chemoradiotherapy for unresectable locally advanced ESCC.
Investigators
Feng Wang
Doctor
The First Affiliated Hospital of Zhengzhou University
Eligibility Criteria
Inclusion Criteria
- •Age 18-75 years old, both men and women;
- •Histology confirmed as esophageal squamous cell carcinoma;
- •T1bN+M0, T2N0-2M0 local progress period;
- •According to RECIST 1.1, at least one measurable lesion;
- •Tissue samples shall be provided for biomarker analysis, preferably newly acquired tissues, and patients who are unable to provide newly acquired tissues may provide 5-8 pieces of 5um thick paraffin sections that are archived and preserved;
- •ECOG: 0\~1;
- •Expected survival period ≥ 12 weeks;
- •The main organs function normally, that is, the following criteria are met:
- •(1) Blood routine examination:
- •ANC ≥ 1.5 × 109 / L;
Exclusion Criteria
- •Does not meet the above inclusion criteria;
- •Those who are allergic or metabolically dying of capecitabine and cisplatin;
- •The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, Hyperthyroidism; patients with vitiligo; Asthma has been completely relieved in childhood, and patients who do not need any intervention after adulthood can be included; asthma patients who require bronchodilators for medical intervention cannot be included);
- •The patient is using immunosuppressive agents or systemic hormonal therapy for immunosuppressive purposes (dose \> 10 mg/day of prednisone or other therapeutic hormones) and continues to be used for 2 weeks prior to enrollment;
- •Radiotherapy contraindications;
- •Patients with any severe and/or uncontrolled diseases;
- •Patients with unsatisfactory blood pressure control (systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100 mmHg); myocardial ischemia or myocardial infarction with grade I or above, arrhythmia (including QT interval ≥480ms) and grade I cardiac insufficiency;
- •Active or uncontrolled serious infections;
- •Liver diseases such as decompensated liver disease, active hepatitis B (HBV-DNA ≥ 104 copies/ml or 2000 IU/ml) or hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the lower limit of detection of the analytical method);
- •Urine routine indicates that urine protein ≥ ++, and confirmed 24-hour urine protein quantitation \> 1.0g;
Arms & Interventions
SHR-1210
SHR-1210
Intervention: SHR-1210
placebo
placebo
Intervention: Placebo
Outcomes
Primary Outcomes
PFS
Time Frame: up to 2 year
Evaluation of anti-PD-1 antibody SHR-1210 for progression-free survival in patients with locally advanced esophageal squamous cell carcinoma who did not develop disease after concurrent chemoradiotherapy
OS
Time Frame: up to 2 year
From date of randomization until the date of death from any cause
Secondary Outcomes
- ORR(up to 2 year)
- DOR(up to 2 year)
- Health-Related Quality of Life (HRQoL)(up to 2 year)
- The incidence and severity of adverse events (AEs)(up to 2 year)