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Study of Sintlimab Maintenance Therapy in Patients With Extensive Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT03983759
Recruitment Status : Not yet recruiting
First Posted : June 12, 2019
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
Henan Cancer Hospital

Brief Summary:
Small cell lung cancer is a highly aggressive malignancy. Currently, there is no effective regimen for patients after the progression offirst-line chemotherapy. The prognosis of patients with extensive disease is very poor, and the improved therapeutic efficacy is urgently needed. Most patients with small cell lung cancer have a long history of smoking, and the tumor mutation burden is relatively high, which provides potential for immunological checkpoint inhibitors represented by PD-1 antibodies. A number of studies have shown that chemotherapy combined with adoptive cellular immunotherapy could prolong the survival of patients. This study is a clinical study to explore the efficacy and safety of maintenance therapy with sintilimab after 4-6 cycles of first-line chemotherapy combined with adoptive cellular immunotherapy in patients with advanced small cell lung cancer.

Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer Extensive Disease Adoptive Cellular Immunotherapy Chemotherapy Maintenance Drug: sintilimab maintenance Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study of Sequential Sequential Sintilimab Maintenance Therapy in Patients With Extensive Small Cell Lung Cancer After Chemotherapy Combined With Adoptive Cellular Immunotherapy
Estimated Study Start Date : June 20, 2019
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: treatment group

phlebotomation 50ml 1-7 days before chemotherapy for culture of R-CIK cells chemotherapeutic regimen EP or EC as follows: VP-16 100mg/m2 D1-3 plus cisplatin 75mg/m2 D1 or VP-16 100mg/m2 D1-3 plus carboplatin AUC=5 D1 R-CIK cells were transfused back to the patients 2-7 days after the end of chemotherapy, and the amount of R-CIK cells returned each time was about 5×109 three weeks each cycle efficacy evaluated every two cycles patients with the efficay is CR, PR or SD after 4-6 cycles enter the sintilimab maintenance therapy for one year or until the progression of disease, or occurrence of intolerable adverse events.

the dose of sintilimab is fixed dose of 200mg every three weeks

Drug: sintilimab maintenance
the patients with CR, PR or SD after the chemotherapy plus R-CIK will receive sintilimab maintenance therapy. The dose of sintilimab is fixed at 200mg every three weeks.




Primary Outcome Measures :
  1. median survival time [ Time Frame: two years. ]
    the period from the day of enrollment to the date of death


Secondary Outcome Measures :
  1. progression-free survival [ Time Frame: six months ]
    the period from the day of enrollment to the date of confirmed progression or death depending on which one occurs first.

  2. objective response rate of sintilimab [ Time Frame: six month ]
    from the date of first dose of sintilimab to the date of confirmed progression following

  3. adverse events rate of sintilimab [ Time Frame: one year ]
    the rate of adverse events during the maintenance therapy of sintilimab



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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:

  • small cell lung cancer confirmed by pathology
  • extensive small cell lung cancer by imaging
  • at least one measurable lesion by RECIST 1.1
  • ECOG 0-1
  • adequate organ function
  • no other severe diseases conflicting with this regimen (such as autoimmune diseases, immunodeficiency, organ transplantation, etc)
  • no history of other maliganancies
  • Women of childbearing period must examinate for a negative pregnancy test within 7 days, use appropriate contraceptive measures during the study and 6 months after the trial.
  • agreement to participate in the study and signed informed consent from the patients

Exclusion Criteria:

  • serious infectious diseases four weeks before enrollment
  • requirement intermittent use of bronchodilators or medical interventions;
  • the use of immunosuppressants before the enrollment, the amount of immunosuppressant used ≥10mg / day oral prednisone for more than 2 weeks;
  • severe allergies
  • severe mental disorders
  • abnormal coagulation function
  • previous or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, severe lung damage, etc.
  • other situations considered by investigators not meet the inclusion criteria (including but not limited to symptomatic brain metastases)

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): NCT03983759


Contacts
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Contact: Quanli Gao, Dr. +86-15038171966 gaoquanli2015@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: NCT03983759     History of Changes
Other Study ID Numbers: HenanCH immunotherapy002
First Posted: June 12, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms