The Efficacy of PD-1 Antibody Sintilimab on Early-stage Multiple Primary Lung Cancer With Ground Glass Density.

• Status: Unknown status
• Trial end date: 2020-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of Guangzhou Medical University
• Treatments: Antibodies; Immunoglobulins

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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