Clinical trial NCT04026841: The Efficacy of PD-1 Antibody Sintilimab on Early-stage Multiple Primary Lung Cancer With Ground Glass Density.
Official title: The Efficacy of PD-1 Antibody Sintilimab on Early-stage Multiple Primary Lung Cancer With Ground Glass Density: A Prospective Interventional Two-stage Simon Design Phase II Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Multiple Primary Lung Cancers
Keywords: ground-glass nodule
ground-glass density
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2019-07-19
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Clinical trials with a single arm
Primary purpose: TREATMENT

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 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 ).

Eligibility 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

Primary outcomes:
measure: ORR of target lesions.
timeFrame: 3 months
Secondary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 3 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Thoracic Surgery and Oncology, The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
affiliation: The First Affiliated Hospital of Guangzhou Medical University
name: Jianxing He, MD
role: PRINCIPAL_INVESTIGATOR
References: