the"Fuzheng" Therapy of TCM to Improve the Survival Quality of Early-stage NSCLC by Intervening the CTCs (CTC-TCM-FZ)
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ClinicalTrials.gov Identifier: NCT02603003 |
Recruitment Status :
Completed
First Posted : November 11, 2015
Last Update Posted : September 20, 2019
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Sponsor:
Shanghai University of Traditional Chinese Medicine
Information provided by (Responsible Party):
jianhuitian, Shanghai University of Traditional Chinese Medicine
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non-small Cell Lung Cancer(NSCLC) | Drug: JinFuKang Drug: Cisplatin Drug: Pemetrexed | Phase 1 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 218 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | A Study on the"Fuzheng"Therapy Promoted Immune Reconstitution to Improve the Survival of Early-stage Lung Cancer After Surgical Operation |
Study Start Date : | June 2015 |
Actual Primary Completion Date : | September 1, 2019 |
Actual Study Completion Date : | September 1, 2019 |
Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics:
Lung cancer
Drug Information available for:
Pemetrexed
Arm | Intervention/treatment |
---|---|
Placebo Comparator: Cisplatin
Cisplatin
|
Drug: Cisplatin
According to the individual patient's condition
Other Name: Navelbine |
Placebo Comparator: Pemetrexed
Pemetrexed
|
Drug: Pemetrexed
According to the individual patient's condition
Other Name: Pemetrexeddisodium for Injection |
Experimental: Jinfukang
Jinfukang
|
Drug: JinFuKang
po.tid.30ml
Other Name: Jin Fukang oral liquid Drug: Cisplatin According to the individual patient's condition
Other Name: Navelbine Drug: Pemetrexed According to the individual patient's condition
Other Name: Pemetrexeddisodium for Injection |
Primary Outcome Measures :
- Progression-Free Survival [ 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. ]It is decided by a doctor via the clinical examinations
Secondary Outcome Measures :
- Circulating Tumor Cell [ Time Frame: 24months ]It is decided by a doctor via the clinical examinations
- Overall survival [ Time Frame: Two years ]It is decided by a doctor via the clinical examinations
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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.
No Contacts or Locations Provided
Responsible Party: | jianhuitian, Clinical Professor, Shanghai University of Traditional Chinese Medicine |
ClinicalTrials.gov Identifier: | NCT02603003 |
Other Study ID Numbers: |
Longhua Hospital TJH20151021 ( Registry Identifier: TIAN Jianhui ) LB20151106 ( Registry Identifier: Robin ) |
First Posted: | November 11, 2015 Key Record Dates |
Last Update Posted: | September 20, 2019 |
Last Verified: | September 2019 |
Keywords provided by jianhuitian, Shanghai University of Traditional Chinese Medicine:
Circulating tumor cells(CTCs) Traditional Chinese Medicine(TCM) Myeloid-derived suppressor cells(MDSCs) |
Additional relevant MeSH terms:
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
Pemetrexed Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |