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Teripalimab Plus Chemotherapy in Local Advanced Esophageal Cancer

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ClinicalTrials.gov Identifier: NCT03985670
Recruitment Status : Not yet recruiting
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Henan Cancer Hospital

Tracking Information
First Submitted Date  ICMJE June 10, 2019
First Posted Date  ICMJE June 14, 2019
Last Update Posted Date June 14, 2019
Estimated Study Start Date  ICMJE June 20, 2019
Estimated Primary Completion Date April 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2019)
Pathological complete response rate [ Time Frame: two months ]
the proportion of patients got pathological complete response rate
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2019)
  • occurrence rate of adverse events [ Time Frame: three month ]
    the occurrence of adverse events
  • disease-free survival rate [ Time Frame: three years ]
    the proportion of patients without relapse
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Teripalimab Plus Chemotherapy in Local Advanced Esophageal Cancer
Official Title  ICMJE Neoadjuvant Teripalimab Plus Chemotherapy in Local Advanced Esophageal Squamous Cancer
Brief Summary The prognosis of locally advanced esophageal squamous cell carcinoma is poor,the role of chemotherapy as neoadjuvant therapy in locally advanced esophageal cancer has been established, which can convert some unresectable esophageal cancer into resectable esophageal cancer.PD-1 antibody has been shown to improve the pathological complete response rate in NSCLC, however, the data in neoadjuvant of esophageal squamous carcinoma is relatively rare. This study was designed to know the value of PD-1 antibody in neoadjuvant therapy of esophageal cancer.
Detailed Description The prognosis of locally advanced esophageal squamous cell carcinoma is poor, the 5-year survival rate is less than 50%. It is necessary to conduct studies in these patients to reduce the rate of postoperative recurrence and prolong the disease-free survival. The role of chemotherapy as neoadjuvant therapy in locally advanced esophageal cancer has been established, which can convert some unresectable esophageal cancer into resectable esophageal cancer. The PD-1 antibody, teripalimab, is an immunological checkpoint inhibitor that has shown clinical efficacy in advanced esophageal cancer, but there has been relatively few data on neoadjuvant therapy. This study was designed to comprehend the pathological complete response rate, disease-free survival, and safety of neoadjuvant therapy with chemotherapy plus teriprilin patients with locally advanced esophageal squamous cell carcinoma.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
patients with local advanced esophageal squamous cell carcinoma receive two cycle of neoadjuvant chemotherapy and PD-1 antibody in the same day or chemotherapy followed by PD-1 antibody, and then surgery
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Squamous Cell Carcinoma
  • Esophageal Cancer
  • Perioperative Period
Intervention  ICMJE
  • Drug: teripalimab plus chemotherapy
    teripalimab 240mg d1 paclitaxel 150mg/m2 d1 cisplatin 70mg/m2 d1
    Other Name: teripalimab and chemotherapy given on the same day
  • Drug: chemotherapy plus teripalimab
    paclitaxel 150mg/m2 d1 cisplatin 70mg/m2 d1 teripalimab 240mg d3
    Other Name: chemotherapy followed by teripalimab
Study Arms  ICMJE
  • Experimental: treatment group
    teripalimab 240mg d1 paclitaxel 150mg/m2 d1 cisplatin 70mg/m2 d1
    Intervention: Drug: teripalimab plus chemotherapy
  • Active Comparator: chemotherapy followed by immunotherapy
    paclitaxel 150mg/m2 d1 cisplatin 70mg/m2 d1 teripalimab 240mg d3
    Intervention: Drug: chemotherapy plus teripalimab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 12, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2023
Estimated Primary Completion Date April 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Thoracic esophageal squamous cell carcinoma diagnosed by pathology
  • no distant metastasis, the diseases could be resected or potentially resectable assessed by thoracic oncologist
  • ECOG score 0-1
  • clinical stage is stage II, III, and IVa according to AJCC 8.0
  • expected lifespan > 3 months
  • enough organ function
  • normal blood pressure, for patients with hypertension, the blood pressure should be controlled in normal level by antihypertension
  • the fasting blood sugar should be ≤ 8mmol / L for diabetic patients
  • no other serious diseases (such as autoimmune diseases, immunodeficiencies, organ transplants) that conflict with this study
  • no history of other malignant tumors
  • women of childbearing period must be tested negative for blood pregnancy within 7 days, and subjects of childbearing age must use appropriate contraceptive measures during the trial period and within 6 months after the trial;
  • The patient agrees to participate in the clinical study and sign the Informed Consent Form.

Exclusion Criteria:

  • suffering from serious infectious diseases within 4 weeks before enrollment;
  • patients with bronchial asthma requires intermittent use of bronchodilators or medical interventions;
  • usage of immunosuppressants before the enrollment, the amount of immunosuppressant used ≥10mg / day oral prednisone for more than 2 weeks
  • clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction, unstable or severe angina, coronary artery bypass surgery, congestive heart failure, and room requiring medical intervention within the first 6 months of enrollment arrhythmia, left ventricular ejection fraction <50%
  • severe allergies
  • severe mental disorder
  • abnormal blood coagulation function (PT>16s, APTT>53s, TT>21s, Fib<1.5g/L), bleeding tendency or receiving thrombolysis or anticoagulant therapy
  • previous or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, severe lung damage, etc
  • other situations evaluated by investigators not meet the enrollment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Quanli Gao, Dr. +86-15038171966 gaoquanli2015@126.com
Contact: Lingdi Zhao, Dr. +86-371-65587483 lingdizhao@126.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03985670
Other Study ID Numbers  ICMJE HenanCH immunotherapy001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Henan Cancer Hospital
Study Sponsor  ICMJE Henan Cancer Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jing Ding, Master Henan Cancer Hospital
PRS Account Henan Cancer Hospital
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP