Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03917966
Recruitment Status : Recruiting
First Posted : April 17, 2019
Last Update Posted : October 1, 2020
Sponsor:
Collaborator:
Jiangsu HengRui Medicine Co., Ltd.
Information provided by (Responsible Party):
Feng Wang, The First Affiliated Hospital of Zhengzhou University

Brief 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

Condition or disease Intervention/treatment Phase
Locally Advanced Esophageal Squamous Cell Carcinoma Drug: SHR-1210+docetaxel+nedaplatin Phase 2

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. Investigator designed a single-arm, open-label, phase II trial of SHR-1210 combined with preoperative chemotherapy for locally advanced esophageal squamous cell carcinoma. 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Phase II Trial of SHR-1210 Combined With Preoperative Chemotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma
Actual Study Start Date : April 7, 2020
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel

Arm Intervention/treatment
Experimental: SHR-1210+Docetaxel+nedaplatin
SHR-1210+Docetaxel+nedaplatin
Drug: SHR-1210+docetaxel+nedaplatin
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.




Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: up to 1 year ]
    CR+PR

  2. Major pathological response(MPR) [ Time Frame: At time of surgery ]
    defined as ≤ 10% residual viable tumor at the time of surgical resection, as assessed by central pathology laboratory.


Secondary Outcome Measures :
  1. Pathological Complete Response (pCR) [ Time Frame: At time of surgery ]
    defined as the absence of any viable tumor at the time of surgical resection, as assessed by central and local pathology laboratory

  2. Overall Survival (OS) [ Time Frame: up to 2 year ]
    defined as the time from randomization to death from any cause during the course of the study.

  3. Disease-Free Survival (DFS) [ Time Frame: up to 2 year ]
    Time after R0 resection to disease recurrence or death

  4. Lymph node derating rate [ Time Frame: At time of surgery ]
    Lymph node derating rate

  5. R0 resection rate [ Time Frame: At time of surgery ]
    R0 resection rate



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03917966


Contacts
Layout table for location contacts
Contact: Feng Wang 13938244776 fengw010@163.com

Locations
Layout table for location information
China, Henan
The First Affiliated Hospital of Zhengzhou University Recruiting
Zhengzhou, Henan, China, 450052
Contact: Feng Wang, doctor         
Sponsors and Collaborators
The First Affiliated Hospital of Zhengzhou University
Jiangsu HengRui Medicine Co., Ltd.
Investigators
Layout table for investigator information
Principal Investigator: Feng Wang The First Affiliated Hospital of Zhengzhou University
Layout table for additonal information
Responsible Party: Feng Wang, Director, The First Affiliated Hospital of Zhengzhou University
ClinicalTrials.gov Identifier: NCT03917966    
Other Study ID Numbers: SHR-1210-02
First Posted: April 17, 2019    Key Record Dates
Last Update Posted: October 1, 2020
Last Verified: September 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Feng Wang, The First Affiliated Hospital of Zhengzhou University:
locally advanced esophageal squamous cell carcinoma
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Docetaxel
Nedaplatin
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action