Status:
UNKNOWN
Serum Autoantibodies in Predicting the Efficacy of Anti-PD-1 Treatment in Patients With Advanced NSCLC
Lead Sponsor:
Shanghai Pulmonary Hospital, Shanghai, China
Conditions:
Lung Cancer
Immunotherapy
Eligibility:
All Genders
18-70 years
Brief Summary
PD-1/PD-L1 blockades have attracted much attention in the treatment of lung cancer, however only a small set of patients can benefit from this kind of immunotherapy. At present, the expression level o...
Eligibility Criteria
Inclusion
- The subjects understood the requirements and risks of the study fully and signed the informed consent form.
- Aged between 18 and 70 years;
- Histologically or cytologically confirmed diagnosis of advanced non-small cell lung cancer.
- Immunohistochemistry of pathological tissue: PD-L1 (22C3) ≥ 1%,Gene detection EGFR (-); ALK (-), ROS1 (-).
- All of these patients have no surgical indications or radical radiotherapy guidelines.
- ECOG PS score 0-1, life expectancy not less than 12 weeks.
- According to RECIST1.1,there is at least one tumor site that can be accurately measured by CT in patients.
- Women of childbearing age had negative pregnancy tests and were willing to accept drugs or intrauterine contraception, while men of childbearing age were willing to accept contraception voluntarily.
- Adequate hematologic function:Peripheral blood neutrophil count \> 2000 cells / uL, Platelet count \> 100\*109 / L; Hemoglobin \>9.0g/dL;Blood total bilirubin \< 2 times normal upper limit, blood AST and ALT ≤ 2. 5 times normal upper line;Inosine clearance ≥ 60ml / min.
Exclusion
- Subjects who needed to receive systemic corticosteroids (prednisone equal to or higher than 10mg / day) or other immunosuppressive drugs within 14 days before enrollment or during the study.
- Subjects who had been vaccinated with antineoplastic vaccine or received antineoplastic drugs with immunostimulatory effect within 4 weeks before entering the group.
- Subjects with known or suspected active autoimmune diseases (vitiligo, type I diabetes, autoimmune thyroiditis requiring hormone replacement therapy, and other autoimmune diseases without recurrence can also be included).
- Subjects with other tumors in the past 5 years, except cervical carcinoma in situ, basal cell carcinoma of the skin, etc.
- Subjects with any unstable systemic diseases (including active infections, poorly controlled hypertension, unstable angina pectoris, angina pectoris that occurred in the past 3 months, congestive heart failure (or New York Heart Association (NYHA) II)), infarcts (within 6 months), severe arrhythmias requiring medication, liver, kidney or metabolic diseases.
- Subjects with previous or present interstitial lung diseases.
- Subjects with systemic infection who need to be treated, HBV surface antigen positive or HCV RNA positive; patients who have previously or currently detected human immunodeficiency virus (HIV) or AIDS.
- Subjects who received targeted therapy or biotherapy at the same time.
- Subjects who are allergic to therapeutic drugs (chemotherapeutic drugs and immune drugs);
- Subjects who underwent major surgery or suffered severe trauma within 2 months before the first treatment;
- Situations that other researchers do not consider appropriate to be included.
- Subjects whose expected survival time is less than 3 months.
Key Trial Info
Start Date :
September 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2022
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04372732
Start Date
September 1 2020
End Date
August 1 2022
Last Update
May 4 2020
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