Status:
UNKNOWN
The Efficacy of PD-1 Antibody Sintilimab on Early-stage Multiple Primary Lung Cancer With Ground Glass Density.
Lead Sponsor:
The First Affiliated Hospital of Guangzhou Medical University
Conditions:
Multiple Primary Lung Cancers
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A single-center,prospective interventional study to explore the efficacy of PD-1 antibody Sintilimab on early-stage multiple primary lung cancer patients with ground-glass nodules in CT scan.
Detailed Description
This study is a single-center,prospective interventional clinical study, all subjects enrolled are multiple primary lung cancer patients with ground-glass density in CT scan.The samples plan for the s...
Eligibility Criteria
Inclusion
- Two or more ground-glass lesions (pure ground glass or partially solid) presented in the CT scan of lung that cannot be operated simultaneously
- There was at least one lung cancer lesion with a diameter of 1-3cm confirmed pathologically or by multidisciplinary team.
- Excluding lymph nodes and distant metastasis through imaging
- ECOG PS 0-1
- Vital organ functions meet the following requirements: 1)The absolute count of neutrophils ≥1.5×109/L 2)Platelet ≥90×109/L 3)Hemoglobin ≥9g/dL 4)Serum albumin ≥3g/dL 5)Thyroid stimulating hormone (TSH) ≤ULN (if abnormal, T3 and T4 levels should be examined at the same time; if T3 and T4 levels are normal, they can be included in the group) 6)Bilirubin ≤ULN 7)ALT and AST≤1.5 ULN 8)AKP≤ 2.5ULN or less 9)Serum creatinine ≤1.5 ULN or creatinine clearance ≥60mL/min
- Subjects volunteered to participate in this study and signed informed consent, with good compliance.
Exclusion
- Non-calcified lesions with diameter more than 3mm are presented
- The presence of any active autoimmune diseases or a history of autoimmune diseases
- Those who have used other drugs in clinical study within 4 weeks before the first time of drug use
- Severe allergic reaction to monoclonal antibody
- Heart clinical symptoms or diseases are not well controlled
- Subjects with congenital or acquired immune deficiency (such as HIV infection) or active hepatitis
- According to the researcher's judgment, the subjects have other factors that may lead to the forced termination of this study
Key Trial Info
Start Date :
July 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2020
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04026841
Start Date
July 30 2019
End Date
February 1 2020
Last Update
August 2 2019
Active Locations (1)
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1
Department of Thoracic Surgery and Oncology, The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China