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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03983759
Other study ID # HenanCH immunotherapy002
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date June 20, 2019
Est. completion date May 31, 2021

Study information

Verified date June 2019
Source Henan Cancer Hospital
Contact Quanli Gao, Dr.
Phone +86-15038171966
Email gaoquanli2015@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date May 31, 2021
Est. primary completion date May 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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)

Study Design


Intervention

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.

Locations

Country Name City State
China Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital Zhengzhou Henan

Sponsors (1)

Lead Sponsor Collaborator
Henan Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary median survival time the period from the day of enrollment to the date of death two years.
Secondary progression-free survival the period from the day of enrollment to the date of confirmed progression or death depending on which one occurs first. six months
Secondary objective response rate of sintilimab from the date of first dose of sintilimab to the date of confirmed progression following six month
Secondary adverse events rate of sintilimab the rate of adverse events during the maintenance therapy of sintilimab one year
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