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

Multiple Primary Lung Cancers Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04026841
• Other study ID #: CCTC1901
• Status: Recruiting
• Phase: Phase 2
• Start date: July 30, 2019
• Est. completion date: February 1, 2020

Study information

• Verified date: July 2019
• Source: The First Affiliated Hospital of Guangzhou Medical University
• Contact: Jianxing He, MD
• Phone: +86-02-83062808
• Email: hejx[@]vip.163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 ).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: February 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Multiple Primary Lung Cancers

Intervention

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

Locations

Country	Name	City	State
China	Department of Thoracic Surgery and Oncology, The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR of target lesions.	The objective response rate will be evaluated after 4 courses of treatment	3 months
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	The safty of PD-1 Antibody Sintilimab	3 months