The Phase II Trial of SHR-1210 Combined With Preoperative Chemotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma

• Status: Recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to observe and evaluate the efficacy and safety of SHR-1210 combined with preoperative chemotherapy for locally advanced esophageal squamous cell carcinoma

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

Details

• Lead Sponsor: The First Affiliated Hospital of Zhengzhou University
• Collaborator: Jiangsu HengRui Medicine Co., Ltd.
• Treatments: Albumin-Bound Paclitaxel; Docetaxel; Nedaplatin; Paclitaxel

Criteria

Inclusion Criteria:

1. Age 18-70 years old, both men and women;

2. Histology confirmed as esophageal squamous cell carcinoma;

3. Potentially resectable cT1-4N1M0/T4N0M0 (IIIB or III);

4. ECOG: 0~1;

5. Expected survival period ≥ 12 weeks;

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

(1)Blood routine examination:

a.HB≥90g/L;b.ANC ≥ 1.5 × 109 / L;c.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; 7.Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ normal low limit (50%); 8.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; 9.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 to or sensitive to paclitaxel and nedaplatin;

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. 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;

6. Active or uncontrolled serious infections;

7. 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);

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

9. Pregnant or lactating women;

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

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

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

13. 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;

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