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The Efficacy and Safety of PD-1/PD-L1 Inhibitors Combined With Centipeda Minima (CM) in Lung Cancer

Primary Purpose

Lung Cancer

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Centipeda minima+PD-1/PD-L1 inhibitor
PD-1/PD-L1 inhibitor
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring lung cancer, Centipeda minima, efficacy, safty

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with non-small cell lung cancer diagnosed by histopathology and intended to be treated with PD-1/PD-L1 inhibitors alone meet the following conditions: Patients fully understand this study and voluntarily participate in and sign informed consent. Patients with non-small cell lung cancer (NSCLC) confirmed by histopathology will be treated with PD-1/PD-L1 alone. 18-70 years old, and the expected survival time is more than 6 months. The indexes of stool routine are normal. Exclusion Criteria: Patients who plan to receive other traditional Chinese medicine treatment at the same time during the study period. Those who are hypersensitive to any research drugs or ingredients Those who have severe acute infection and are not controlled; or those who have suppurative and chronic infection and whose wounds are not healed. Obvious gastrointestinal diseases during screening, such as inability to swallow, chronic diarrhea, intestinal obstruction, gastric ulcer and so on. Those who have participated in clinical trials of other drugs within 5 or 4 weeks. Patients with severe heart disease, including congestive heart failure, uncontrollable high-risk arrhythmias, unstable angina pectoris, myocardial infarction, severe valvular heart disease and intractable hypertension. Suffering from uncontrollable neurological, mental illness or mental disorders, poor compliance, unable to cooperate and describe the treatment response. Primary brain tumor or central nervous system metastasis is not controlled, with obvious intracranial hypertension or neuropsychiatric symptoms. Those with bleeding tendency; evidence of hereditary hemorrhagic physique or blood coagulation disorder Severe allergic / allergic reaction to humanized antibody. Diagnosed with immunodeficiency or receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 14 days prior to the first administration of the study, allowing the use of physiological doses of glucocorticoids (prednisone or equivalent for ≤ 10mg/ days). Exclude subjects with active, known or suspected autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hypothyroidism, including but not limited to these diseases or syndromes). Vulnerable groups: such as patients with serious diseases, incapacitated, illiterate, mentally retarded / related mental disorders, children. -

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    CM group

    Control group

    Arm Description

    CM+PD-1/PD-L1 inhibitor

    PD-1/PD-L1 inhibitor

    Outcomes

    Primary Outcome Measures

    Progression-free survival (PFS)
    Progression-free survival
    the temperature
    Vital signs
    blood pressure
    Vital signs
    complete blood count
    laboratory index
    adverse event and severe adverse event
    adverse event and severe adverse event, according to NCI-CTC V5.0

    Secondary Outcome Measures

    Objective Response Rate (ORR)
    Objective Response Rate
    disease control rate (DCR)
    disease control rate

    Full Information

    First Posted
    February 7, 2023
    Last Updated
    February 17, 2023
    Sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05735028
    Brief Title
    The Efficacy and Safety of PD-1/PD-L1 Inhibitors Combined With Centipeda Minima (CM) in Lung Cancer
    Official Title
    A Preliminary Study on the Efficacy and Safety of PD-1/PD-L1 Inhibitors Combined With Centipeda Minima (CM) in Lung Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 7, 2023 (Anticipated)
    Primary Completion Date
    February 7, 2024 (Anticipated)
    Study Completion Date
    February 7, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Lung cancer has a high global cancer morbidity and mortality. At present, PD-1/PD-L1 inhibitors have been approved by FDA to treat different types of lung cancer, but the efficacy is not good. There is an urgent need to develop drugs that can significantly enhance the efficacy of PD-1/PD-L1 inhibitors to enable tumor patients to obtain lasting anti-tumor response. Centipeda minima (CM), as a commonly used traditional Chinese medicine, is relatively safe. Previous studies found that it can inhibit the growth of lung cancer cells. At the level of animal research, the combined use of CM and PD-1/PD-L1 inhibitors produced a stronger anti-lung cancer effect, and did not produce obvious side effects on mice. Based on previous studies, the main purpose of this study was to evaluate the efficacy and safety of PD-1/PD-L inhibitors combined with herbivorous herbivores (CM) in the treatment of lung cancer.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lung Cancer
    Keywords
    lung cancer, Centipeda minima, efficacy, safty

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    8 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    CM group
    Arm Type
    Experimental
    Arm Description
    CM+PD-1/PD-L1 inhibitor
    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    PD-1/PD-L1 inhibitor
    Intervention Type
    Drug
    Intervention Name(s)
    Centipeda minima+PD-1/PD-L1 inhibitor
    Intervention Description
    Before routine anti-PD-1/PD-L1 treatment, patients were treated with Centipeda minima, and15g Centipeda minima decoction was taken twice a day for 5 consecutive days.
    Intervention Type
    Drug
    Intervention Name(s)
    PD-1/PD-L1 inhibitor
    Intervention Description
    PD-1/PD-L1 inhibitor
    Primary Outcome Measure Information:
    Title
    Progression-free survival (PFS)
    Description
    Progression-free survival
    Time Frame
    through study completion, an average of 2 year.
    Title
    the temperature
    Description
    Vital signs
    Time Frame
    through study completion, an average of 2 year.
    Title
    blood pressure
    Description
    Vital signs
    Time Frame
    through study completion, an average of 2 year.
    Title
    complete blood count
    Description
    laboratory index
    Time Frame
    through study completion, an average of 2 year.
    Title
    adverse event and severe adverse event
    Description
    adverse event and severe adverse event, according to NCI-CTC V5.0
    Time Frame
    through study completion, an average of 2 year.
    Secondary Outcome Measure Information:
    Title
    Objective Response Rate (ORR)
    Description
    Objective Response Rate
    Time Frame
    through study completion, an average of 2 year.
    Title
    disease control rate (DCR)
    Description
    disease control rate
    Time Frame
    through study completion, an average of 2 year.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with non-small cell lung cancer diagnosed by histopathology and intended to be treated with PD-1/PD-L1 inhibitors alone meet the following conditions: Patients fully understand this study and voluntarily participate in and sign informed consent. Patients with non-small cell lung cancer (NSCLC) confirmed by histopathology will be treated with PD-1/PD-L1 alone. 18-70 years old, and the expected survival time is more than 6 months. The indexes of stool routine are normal. Exclusion Criteria: Patients who plan to receive other traditional Chinese medicine treatment at the same time during the study period. Those who are hypersensitive to any research drugs or ingredients Those who have severe acute infection and are not controlled; or those who have suppurative and chronic infection and whose wounds are not healed. Obvious gastrointestinal diseases during screening, such as inability to swallow, chronic diarrhea, intestinal obstruction, gastric ulcer and so on. Those who have participated in clinical trials of other drugs within 5 or 4 weeks. Patients with severe heart disease, including congestive heart failure, uncontrollable high-risk arrhythmias, unstable angina pectoris, myocardial infarction, severe valvular heart disease and intractable hypertension. Suffering from uncontrollable neurological, mental illness or mental disorders, poor compliance, unable to cooperate and describe the treatment response. Primary brain tumor or central nervous system metastasis is not controlled, with obvious intracranial hypertension or neuropsychiatric symptoms. Those with bleeding tendency; evidence of hereditary hemorrhagic physique or blood coagulation disorder Severe allergic / allergic reaction to humanized antibody. Diagnosed with immunodeficiency or receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 14 days prior to the first administration of the study, allowing the use of physiological doses of glucocorticoids (prednisone or equivalent for ≤ 10mg/ days). Exclude subjects with active, known or suspected autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hypothyroidism, including but not limited to these diseases or syndromes). Vulnerable groups: such as patients with serious diseases, incapacitated, illiterate, mentally retarded / related mental disorders, children. -
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ying Dong, Doctorate
    Phone
    13666669105
    Email
    dongying74@zju.edu.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ying Dong, Doctorate
    Organizational Affiliation
    2ndAffiliated Hospital, School of Medicine, Zhejiang University, China
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    The Efficacy and Safety of PD-1/PD-L1 Inhibitors Combined With Centipeda Minima (CM) in Lung Cancer

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