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theFuzheng Therapy of TCM to Improve the Survival Quality of Early-stage NSCLC by Intervening the CTCs

A Study on theFuzhengTherapy Promoted Immune Reconstitution to Improve the Survival of Early-stage Lung Cancer After Surgical Operation

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02603003
Acronym
CTC-TCM-FZ
Enrollment
218
Registered
2015-11-11
Start date
2015-06-30
Completion date
2019-09-01
Last updated
2019-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer(NSCLC)

Keywords

Circulating tumor cells(CTCs), Traditional Chinese Medicine(TCM), Myeloid-derived suppressor cells(MDSCs)

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.

Interventions

po.tid.30ml

DRUGCisplatin

According to the individual patient's condition

DRUGPemetrexed

According to the individual patient's condition

Sponsors

Shanghai University of Traditional Chinese Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Progression-Free SurvivalThe 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

MeasureTime frameDescription
Circulating Tumor Cell24monthsIt is decided by a doctor via the clinical examinations
Overall survivalTwo yearsIt is decided by a doctor via the clinical examinations

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026