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

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ClinicalTrials.gov Identifier: NCT04026841
Recruitment Status : Recruiting
First Posted : July 19, 2019
Last Update Posted : August 2, 2019
Sponsor:
Information provided by (Responsible Party):
Jianxing He, The First Affiliated Hospital of Guangzhou Medical University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Multiple Primary Lung Cancers Drug: PD-1 antibody Sintilimab Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Clinical trials with a single arm
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : July 30, 2019
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arms and Interventions
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Arm Intervention/treatment
Experimental: PD-1 Antibody Sintilimab
Patients receive the treatment of PD-1 antibody Sintilimab
 Drug: PD-1 antibody Sintilimab
Patients in experimental group receive the treatment of PD-1 antibody Sintilimab


Outcome Measures
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Primary Outcome Measures :
  1. ORR of target lesions. [ Time Frame: 3 months ]
    The objective response rate will be evaluated after 4 courses of treatment


Secondary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 3 months ]
    The safty of PD-1 Antibody Sintilimab


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04026841


Contacts
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Contact: Jianxing He, MD +86-02-83062808 hejx@vip.163.com
Contact: Wenhua Liang, PhD +86-02-83062808 liangwh1987@163.com

Locations
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China, Guangdong
Department of Thoracic Surgery and Oncology, The First Affiliated Hospital of Guangzhou Medical University Recruiting
Guangzhou, Guangdong, China
Contact: Wenhua Liang, PhD    0086-20-83062114    liangwh1987@163.com   
Contact: Wenhua Liang, PhD         
Sponsors and Collaborators
The First Affiliated Hospital of Guangzhou Medical University
Investigators
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Principal Investigator: Jianxing He, MD The First Affiliated Hospital of Guangzhou Medical University
More Information
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Responsible Party: Jianxing He, professor, The First Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier: NCT04026841    
Other Study ID Numbers: CCTC1901
First Posted: July 19, 2019    Key Record Dates
Last Update Posted: August 2, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jianxing He, The First Affiliated Hospital of Guangzhou Medical University:
ground-glass nodule
ground-glass density
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
 Lung Diseases
Respiratory Tract Diseases
Antibodies
Immunologic Factors
Physiological Effects of Drugs