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

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.

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04026841

Enrollment

Registered

2019-07-19

Start date

2019-07-30

Completion date

2020-02-01

Last updated

2019-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Primary Lung Cancers

Keywords

ground-glass nodule, ground-glass density

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 ).

Interventions

DRUGPD-1 antibody Sintilimab

Patients in experimental group receive the treatment of PD-1 antibody Sintilimab

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Clinical trials with a single arm

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
ORR of target lesions.	3 months	The objective response rate will be evaluated after 4 courses of treatment

Secondary

Measure	Time frame	Description
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	3 months	The safty of PD-1 Antibody Sintilimab

Countries

China

Contacts

Primary ContactJianxing He, MD

hejx@vip.163.com+86-02-83062808

Backup ContactWenhua Liang, PhD

liangwh1987@163.com+86-02-83062808

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026