The Efficacy of PD-1 Antibody Sintilimab on Early-stage Multiple Primary Lung Cancer With Ground Glass Density.
Primary Purpose
Multiple Primary Lung Cancers
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
PD-1 antibody Sintilimab
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Primary Lung Cancers focused on measuring ground-glass nodule, ground-glass density
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
Sites / Locations
- Department of Thoracic Surgery and Oncology, The First Affiliated Hospital of Guangzhou Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PD-1 Antibody Sintilimab
Arm Description
Patients receive the treatment of PD-1 antibody Sintilimab
Outcomes
Primary Outcome Measures
ORR of target lesions.
The objective response rate will be evaluated after 4 courses of treatment
Secondary Outcome Measures
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
The safty of PD-1 Antibody Sintilimab
Full Information
NCT ID
NCT04026841
First Posted
July 17, 2019
Last Updated
July 31, 2019
Sponsor
The First Affiliated Hospital of Guangzhou Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04026841
Brief Title
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
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 30, 2019 (Actual)
Primary Completion Date
February 1, 2020 (Anticipated)
Study Completion Date
February 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital of Guangzhou Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 ).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Primary Lung Cancers
Keywords
ground-glass nodule, ground-glass density
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Clinical trials with a single arm
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PD-1 Antibody Sintilimab
Arm Type
Experimental
Arm Description
Patients receive the treatment of PD-1 antibody Sintilimab
Intervention Type
Drug
Intervention Name(s)
PD-1 antibody Sintilimab
Intervention Description
Patients in experimental group receive the treatment of PD-1 antibody Sintilimab
Primary Outcome Measure Information:
Title
ORR of target lesions.
Description
The objective response rate will be evaluated after 4 courses of treatment
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Description
The safty of PD-1 Antibody Sintilimab
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianxing He, MD
Phone
+86-02-83062808
Email
hejx@vip.163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wenhua Liang, PhD
Phone
+86-02-83062808
Email
liangwh1987@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianxing He, MD
Organizational Affiliation
The First Affiliated Hospital of Guangzhou Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Thoracic Surgery and Oncology, The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenhua Liang, PhD
Phone
0086-20-83062114
Email
liangwh1987@163.com
First Name & Middle Initial & Last Name & Degree
Wenhua Liang, PhD
12. IPD Sharing Statement
Learn more about this trial
The Efficacy of PD-1 Antibody Sintilimab on Early-stage Multiple Primary Lung Cancer With Ground Glass Density.
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