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the"Fuzheng" Therapy of TCM to Improve the Survival Quality of Early-stage NSCLC by Intervening the CTCs (CTC-TCM-FZ)

Primary Purpose

Non-small Cell Lung Cancer(NSCLC)

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
JinFuKang
Cisplatin
Pemetrexed
Sponsored by
Shanghai University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer(NSCLC) focused on measuring Circulating tumor cells(CTCs), Traditional Chinese Medicine(TCM), Myeloid-derived suppressor cells(MDSCs)

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Complete resection was accepted in IIa ~ Ⅲa stage, and the pathological changes could confirmed as non small cell lung cancer patients;
  2. Patients receiving chemotherapy for the first time in 6 weeks after surgery;
  3. Age from 18 Years to 70 Years;
  4. The liver and renal function were normal,and no other disease.
  5. Patients compliance is good ang can understand the situation of this study and signed informed consent

Exclusion Criteria:

  1. Patients without clear pathological diagnosis;
  2. The expected survival period is morn than 6 months;
  3. Patients with serious diseases such as heart, liver, kidney and hematopoietic system;
  4. Patients with pregnancy or lactation;
  5. Persons with a history of less control.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Placebo Comparator

    Placebo Comparator

    Experimental

    Arm Label

    Cisplatin

    Pemetrexed

    Jinfukang

    Arm Description

    Cisplatin

    Pemetrexed

    Jinfukang

    Outcomes

    Primary Outcome Measures

    Progression-Free Survival
    It is decided by a doctor via the clinical examinations

    Secondary Outcome Measures

    Circulating Tumor Cell
    It is decided by a doctor via the clinical examinations
    Overall survival
    It is decided by a doctor via the clinical examinations

    Full Information

    First Posted
    October 21, 2015
    Last Updated
    September 18, 2019
    Sponsor
    Shanghai University of Traditional Chinese Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02603003
    Brief Title
    the"Fuzheng" Therapy of TCM to Improve the Survival Quality of Early-stage NSCLC by Intervening the CTCs
    Acronym
    CTC-TCM-FZ
    Official Title
    A Study on the"Fuzheng"Therapy Promoted Immune Reconstitution to Improve the Survival of Early-stage Lung Cancer After Surgical Operation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2015 (undefined)
    Primary Completion Date
    September 1, 2019 (Actual)
    Study Completion Date
    September 1, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shanghai University of Traditional Chinese Medicine

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Metastasis is the leading cause of death in patients with lung cancer, and circulating tumor cells(CTCs) play a key role in the process of distant metastasis. The investigators' study will elaborate the clinical significance of CTCs intervented by Traditional Chinese Medicine(TCM) in lung cancer from the diagnosis and clinical staging,metastasis and recurrence, individual treatment and prognosis and so on, in order to provide a new direction for the treatment of lung cancer.
    Detailed Description
    Metastasis is the leading cause of death in patients with lung cancer, and circulating tumor cells play a key role in the process of distant metastasis.In recent years, research results have shown that CTCs may become a emerging marker and new target in the treatment of lung cancer. The investigators' study will elaborate the clinical significance of CTCs intervented by TCM in lung cancer from the diagnosis and clinical staging,metastasis and recurrence, individual treatment and prognosis and so on, in order to provide a new direction for the treatment of lung cancer.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non-small Cell Lung Cancer(NSCLC)
    Keywords
    Circulating tumor cells(CTCs), Traditional Chinese Medicine(TCM), Myeloid-derived suppressor cells(MDSCs)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    218 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cisplatin
    Arm Type
    Placebo Comparator
    Arm Description
    Cisplatin
    Arm Title
    Pemetrexed
    Arm Type
    Placebo Comparator
    Arm Description
    Pemetrexed
    Arm Title
    Jinfukang
    Arm Type
    Experimental
    Arm Description
    Jinfukang
    Intervention Type
    Drug
    Intervention Name(s)
    JinFuKang
    Other Intervention Name(s)
    Jin Fukang oral liquid
    Intervention Description
    po.tid.30ml
    Intervention Type
    Drug
    Intervention Name(s)
    Cisplatin
    Other Intervention Name(s)
    Navelbine
    Intervention Description
    According to the individual patient's condition
    Intervention Type
    Drug
    Intervention Name(s)
    Pemetrexed
    Other Intervention Name(s)
    Pemetrexeddisodium for Injection
    Intervention Description
    According to the individual patient's condition
    Primary Outcome Measure Information:
    Title
    Progression-Free Survival
    Description
    It is decided by a doctor via the clinical examinations
    Time Frame
    The progression disease is assessed based on CT or PET-CT every six months from date of randomization and the endpoints is the date of first documented progression or date of death due to lung cancer,assessed up to Two years.
    Secondary Outcome Measure Information:
    Title
    Circulating Tumor Cell
    Description
    It is decided by a doctor via the clinical examinations
    Time Frame
    24months
    Title
    Overall survival
    Description
    It is decided by a doctor via the clinical examinations
    Time Frame
    Two years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Complete resection was accepted in IIa ~ Ⅲa stage, and the pathological changes could confirmed as non small cell lung cancer patients; Patients receiving chemotherapy for the first time in 6 weeks after surgery; Age from 18 Years to 70 Years; The liver and renal function were normal,and no other disease. Patients compliance is good ang can understand the situation of this study and signed informed consent Exclusion Criteria: Patients without clear pathological diagnosis; The expected survival period is morn than 6 months; Patients with serious diseases such as heart, liver, kidney and hematopoietic system; Patients with pregnancy or lactation; Persons with a history of less control.

    12. IPD Sharing Statement

    Learn more about this trial

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