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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-30

Study Completion Date

2020-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Phase II Study of Anti-PD-1 Antibody, Sintilimab, as Second-line Therapy for Biomarker-selected Advanced or Metastatic NSCLC

NCT04612673

Non-small Cell Lung Cancer

UNKNOWN PHASE2

Sintilimab in Combination With Chemoradiotherapy in High-risk Locoregionally-advanced Nasopharyngeal Carcinoma

NCT05707819

Nasopharyngeal Carcinoma Sintilimab

RECRUITING

A Study of Anti-PD1 Antibody-activated TILs in Non-small Cell Lung Cancer

NCT03903887

Non-small Cell Lung Cancer

UNKNOWN PHASE1/PHASE2

Neoadjuvant Immunotherapy in Early Stage Non-small-cell Lung Cancer Presenting as Synchronous Ground-glass Nodules

NCT04047186

Multiple Pulmonary Nodules

COMPLETED PHASE2

Anti-PD-1 in Combination With Chemotherapy as First-Line Treatment to Lung Cancer

NCT03432598

Locally Advanced Lung Cancer; Metastatic Lung Cancer

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 ).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Primary Lung Cancers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Clinical trials with a single arm

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PD-1 Antibody Sintilimab

Patients receive the treatment of PD-1 antibody Sintilimab

Group Type EXPERIMENTAL

PD-1 antibody Sintilimab

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PD-1 antibody Sintilimab

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No