A Phase II Study of SHR-1210 vs Placebo as Consolidation Chemotherapy After Radical Concurrent Chemoradiotherapy in Locally Advanced ESCC

• Status: Unknown status
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of Zhengzhou University
• Collaborator: Jiangsu HengRui Medicine Co., Ltd.

Criteria

Inclusion Criteria:

1. Age 18-75 years old, both men and women;

2. Histology confirmed as esophageal squamous cell carcinoma;

3. T1bN+M0, T2N0-2M0 local progress period;

4. According to RECIST 1.1, at least one measurable lesion;

5. 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;

6. ECOG: 0~1;

7. Expected survival period ≥ 12 weeks;

8. The main organs function normally, that is, the following criteria are met:

(1) Blood routine examination:

1. HB≥90g/L;

2. ANC ≥ 1.5 × 109 / L;

3. PLT ≥ 80 × 109 / L; (2) Biochemical examination:

a. ALB ≥ 30g / L; b. ALT and AST ≤ 2.5ULN; if there is liver metastasis, ALT and AST ≤ 5ULN; c. TBIL ≤ 1.5ULN; d. plasma Cr ≤ 1.5ULN or creatinine clearance (CCr) ≥ 60ml / min;

9. Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ normal low limit (50%); 10. Women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; negative serum or urine pregnancy test within 7 days prior to study enrollment And must be non-lactating patients; males should agree to patients who must use contraception during the study period and within 6 months after the end of the study period; 11. Subjects voluntarily joined the study, signed informed consent, and were well-adhered to follow-up.

Exclusion Criteria:

1. Does not meet the above inclusion criteria;

2. Those who are allergic or metabolically dying of capecitabine and cisplatin;

3. 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);

4. 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;

5. Radiotherapy contraindications;

6. Patients with any severe and/or uncontrolled diseases;

7. 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;

8. Active or uncontrolled serious infections;

9. 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);

10. Urine routine indicates that urine protein ≥ ++, and confirmed 24-hour urine protein quantitation > 1.0g;

11. Imaging shows that the tumor has invaded the important perivascular circumference or that the patient is likely to invade the important blood vessels and cause fatal bleeding during the follow-up study;

12. Pregnant or lactating women;

13. Patients with other malignancies within 5 years (except for basal cell carcinoma and cervical carcinoma in situ) that have been cured;

14. Patients with a history of psychotropic substance abuse who are unable to quit or have a mental disorder;

15. Patients who have participated in other drug clinical trials within four weeks;

16. At the discretion of the investigator, there are patients with serious concomitant disease that compromises patient safety or affects the patient's completion of the study;

17. The investigator believes that it is not suitable for inclusion.