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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

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.

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma Esophageal Cancer Perioperative Period Drug: teripalimab plus chemotherapy Drug: chemotherapy plus teripalimab Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Official Title: Neoadjuvant Teripalimab Plus Chemotherapy in Local Advanced Esophageal Squamous Cancer
Estimated Study Start Date : June 20, 2019
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: treatment group
teripalimab 240mg d1 paclitaxel 150mg/m2 d1 cisplatin 70mg/m2 d1
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

Active Comparator: chemotherapy followed by immunotherapy
paclitaxel 150mg/m2 d1 cisplatin 70mg/m2 d1 teripalimab 240mg d3
Drug: chemotherapy plus teripalimab
paclitaxel 150mg/m2 d1 cisplatin 70mg/m2 d1 teripalimab 240mg d3
Other Name: chemotherapy followed by teripalimab




Primary Outcome Measures :
  1. Pathological complete response rate [ Time Frame: two months ]
    the proportion of patients got pathological complete response rate


Secondary Outcome Measures :
  1. occurrence rate of adverse events [ Time Frame: three month ]
    the occurrence of adverse events

  2. disease-free survival rate [ Time Frame: three years ]
    the proportion of patients without relapse



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03985670


Contacts
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Contact: Quanli Gao, Dr. +86-15038171966 gaoquanli2015@126.com
Contact: Lingdi Zhao, Dr. +86-371-65587483 lingdizhao@126.com

Locations
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China, Henan
Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Zhengzhou, Henan, China, 450008
Sponsors and Collaborators
Henan Cancer Hospital
Investigators
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Principal Investigator: Jing Ding, Master Henan Cancer Hospital

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Responsible Party: Henan Cancer Hospital
ClinicalTrials.gov Identifier: NCT03985670     History of Changes
Other Study ID Numbers: HenanCH immunotherapy001
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Esophageal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action