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

Phase 2

• Conditions: Multiple Primary Lung Cancers
• Interventions: Drug: PD-1 antibody Sintilimab

• Registration Number: NCT04026841
• Lead Sponsor: The First Affiliated Hospital of Guangzhou Medical University

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 ).

Study Timeline

• Status Verified: 2019-07
• Study First Submitted: 2019-07-17
• Study First Submitted QC: 2019-07-18
• Study First Posted: 2019-07-19
• Study Start: 2019-07-30
• Last Update Submitted: 2019-07-31
• Last Update Posted: 2019-08-02
• Primary Completion: 2020-02-01
• Study Completion: 2020-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PD-1 Antibody Sintilimab	PD-1 antibody Sintilimab	Patients receive the treatment of PD-1 antibody Sintilimab

Primary Outcome Measures

Name	Time	Method
ORR of target lesions.	3 months	The objective response rate will be evaluated after 4 courses of treatment

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Thoracic Surgery and Oncology, The First Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China