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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

Tracking Information
First Submitted Date  ICMJE July 17, 2019
First Posted Date  ICMJE July 19, 2019
Last Update Posted Date August 2, 2019
Actual Study Start Date  ICMJE July 30, 2019
Estimated Primary Completion Date February 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2019)
ORR of target lesions. [ Time Frame: 3 months ]
The objective response rate will be evaluated after 4 courses of treatment
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2019)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2019)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 3 months ]
The safty of PD-1 Antibody Sulituzumab
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy of PD-1 Antibody Sintilimab on Early-stage Multiple Primary Lung Cancer With Ground Glass Density.
Official Title  ICMJE 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Clinical trials with a single arm
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Primary Lung Cancers
Intervention  ICMJE Drug: PD-1 antibody Sintilimab
Patients in experimental group receive the treatment of PD-1 antibody Sintilimab
Study Arms  ICMJE Experimental: PD-1 Antibody Sintilimab
Patients receive the treatment of PD-1 antibody Sintilimab
Intervention: Drug: PD-1 antibody Sintilimab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 18, 2019)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 1, 2020
Estimated Primary Completion Date February 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jianxing He, MD +86-02-83062808 hejx@vip.163.com
Contact: Wenhua Liang, PhD +86-02-83062808 liangwh1987@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04026841
Other Study ID Numbers  ICMJE CCTC1901
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jianxing He, The First Affiliated Hospital of Guangzhou Medical University
Study Sponsor  ICMJE The First Affiliated Hospital of Guangzhou Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jianxing He, MD The First Affiliated Hospital of Guangzhou Medical University
PRS Account The First Affiliated Hospital of Guangzhou Medical University
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP