Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: 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

Tracking Information
First Submitted Date  ICMJE June 10, 2019
First Posted Date  ICMJE June 12, 2019
Last Update Posted Date June 13, 2019
Estimated Study Start Date  ICMJE June 20, 2019
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2019)
median survival time [ Time Frame: two years. ]
the period from the day of enrollment to the date of death
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03983759 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2019)
  • 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.
  • objective response rate of sintilimab [ Time Frame: six month ]
    from the date of first dose of sintilimab to the date of confirmed progression following
  • adverse events rate of sintilimab [ Time Frame: one year ]
    the rate of adverse events during the maintenance therapy of sintilimab
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 Study of Sintlimab Maintenance Therapy in Patients With Extensive Small Cell Lung Cancer
Official Title  ICMJE Clinical Study of Sequential Sequential Sintilimab Maintenance Therapy in Patients With Extensive Small Cell Lung Cancer After Chemotherapy Combined With Adoptive Cellular Immunotherapy
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Small Cell Lung Cancer
  • Extensive Disease
  • Adoptive Cellular Immunotherapy
  • Chemotherapy
  • Maintenance
Intervention  ICMJE 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.
Study Arms  ICMJE 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

Intervention: Drug: sintilimab maintenance
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 10, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 31, 2021
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
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
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03983759
Other Study ID Numbers  ICMJE HenanCH immunotherapy002
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
Plan to Share IPD: No
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