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

Guangzhou Medical University

Status and phase

Unknown

Phase 2

Conditions

Multiple Primary Lung Cancers

Treatments

Drug: PD-1 antibody Sintilimab

Study type

Interventional

Funder types

Other

Identifiers

NCT04026841

CCTC1901

Details and patient eligibility

About

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.

Full 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 study was 36 cases.The enrolled patients will receive intravenous infusion of Sintilimab 200mg every 3 weeks up to 4 cycles, and the efficacy will be evaluated after cycle 2 and 4 using RECIST criteria (version 1.1 ).

Enrollment

36 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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