The Phase II Trial of SHR-1210 Combined With Preoperative Chemotherapy or Apatinib for Locally Advanced ESCC

NCT03917966 | Unknown Phase 2

• 1 other identifier: SHR-1210-02
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Locally Advanced Esophageal Squamous Cell Carcinoma

Keywords

locally advanced esophageal squamous cell carcinoma

Outcome Measures

Primary Outcomes (1)

• Major pathological response（MPR）

  defined as ≤ 10% residual viable tumor at the time of surgical resection, as assessed by central pathology laboratory.

  At time of surgery

Secondary Outcomes (5)

• Pathological Complete Response (pCR)

  At time of surgery

• Overall Survival (OS)

  up to 2 year

• Disease-Free Survival (DFS)

  up to 2 year

• Lymph node derating rate

  At time of surgery

• R0 resection rate

  At time of surgery

Study Arms (2)

SHR-1210+Docetaxel+nedaplatin

EXPERIMENTAL

SHR-1210+Docetaxel+nedaplatin

Drug: SHR-1210+docetaxel+nedaplatin

SHR-1210+Apatinib

EXPERIMENTAL

SHR-1210+Apatinib

Drug: SHR-1210+Apatinib

Interventions

SHR-1210+docetaxel+nedaplatin DRUG

neoadjuvant chemotherapy:SHR-1210, 200mg,q2w, a total of 3 times; docetaxel 75mg/m2 ivgtt d1, nedaplatin 75mg/m2 ivgtt d1, q3w, for 2 cycles.The patient was evaluated after 2 cycles of neoadjuvant chemotherapy. The surgery was performed 3-4 weeks after the completion of neoadjuvant chemotherapy.

SHR-1210+Docetaxel+nedaplatin

SHR-1210+Apatinib DRUG

SHR-1210, 200 mg, q2w; Apatinib, 250mg, qd; 4 weeks is a cycle, a total of 2 cycles

SHR-1210+Apatinib

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years old, both men and women;
• Histology confirmed as esophageal squamous cell carcinoma;
• Resectable stage Ⅱ/Ⅲ/Ⅳa（cT2-4aN0-3M0）;
• ECOG: 0\~1;
• Expected survival period≥12 weeks;
• 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;
• Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ normal low limit (50%);
• 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;
• Subjects voluntarily joined the study, signed informed consent, and were well-adhered to follow-up;
• Can swallow tablets normally.

You may not qualify if:

• Those who are allergic to or sensitive to Docetaxel and nedaplatin;
• 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;
• 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;
• Pregnant or lactating women;
• Patients with other malignancies within 5 years (except for basal cell carcinoma and cervical carcinoma in situ) that have been cured;
• Patients with a history of psychotropic substance abuse who are unable to quit or have a mental disorder;
• Patients who have participated in other drug clinical trials within four weeks;
• 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;
• Patients with esophageal squamous cell carcinoma whose primary focus is active bleeding;
• With active ulcer, unhealed wound or fracture;
• Suffer from hypertension and cannot be well controlled by antihypertensive drugs (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg);

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

Study Officials

• Feng Wang

  The First Affiliated Hospital of Zhengzhou University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feng Wang

CONTACT

13938244776; fengw010@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: April 14, 2019
• First Posted: April 17, 2019
• Study Start: April 7, 2020
• Primary Completion: October 7, 2023
• Study Completion: October 7, 2024
• Last Updated: March 4, 2022

Record last verified: 2021-08

Locations

CN (1)