A Phase Ⅱ Trials of Sintilimab as Consolidation Therapy After Radical Concurrent Chemoradiotherapy in Locally Advanced Unresectable ESCC
Overview
- Phase
- Phase 2
- Intervention
- Cisplatin+Capecitabine+Sintilimab
- Conditions
- Esophageal Squamous Cell Carcinoma
- Sponsor
- The First Affiliated Hospital of Zhengzhou University
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Progression-free survival（PFS）
- Last Updated
- 4 years ago
Overview
Brief Summary
The purpose of this study is to observe and evaluate the efficacy and safety of Sintilimab for Consolidation Therapy After Radical Concurrent Chemoradiotherapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma
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 single-arm, open-label, phase II trial of Sintilimab for consolidation therapy after radical concurrent chemoradiotherapylocally advanced esophageal squamous cell carcinoma.The purpose of this study is to observe and evaluate the efficacy and safety of Sintilimab for consolidation therapy after radical concurrent chemoradiotherapy for locally advanced unresectable esophageal squamous cell carcinoma.
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, T2-T4aN0-2M0 locally advanced stage；
- •Tissue samples should be provided for biomarker analysis, and the newly obtained tissues should be selected. Patients who cannot provide newly obtained tissues can provide 5-
- •pieces of 5-um thick paraffin sections;
- •ECOG: 0\~1;
- •Expected survival period ≥ 12 weeks;
- •The main organs function normally, that is, the following criteria are met:
- •Blood routine examination:
- •ANC ≥ 1.5 × 109 / L;
Exclusion Criteria
- •Does not meet the above inclusion criteria;
- •Those who are allergic to or sensitive to capecitabine and cisplatin or metabolic disorders;
- •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;
- •contraindications to radiotherapy;
- •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;
- •The patients whose imaging showed that the tumor had invaded the important vessels or the tumor was likely to invade the important vessels and cause fatal hemorrhage during the follow-up study;
Arms & Interventions
Cisplatin+Capecitabine+Sintilimab
Cisplatin+Capecitabine+Sintilimab
Intervention: Cisplatin+Capecitabine+Sintilimab
Outcomes
Primary Outcomes
Progression-free survival（PFS）
Time Frame: up to 1 year
Evaluation of anti-PD-1 antibody Sintilimab for progression-free survival in patients with locally advanced unresectable esophageal squamous cell carcinoma who did not develop disease after radical concurrent chemoradiotherapy
Secondary Outcomes
- Objective Response Rate，ORR(At time of surgery)