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

Non-small Cell Lung Cancer(NSCLC) Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02603003
• Other study ID #: Longhua Hospital
• Secondary ID: TJH20151021LB201
• Status: Completed
• Phase: Phase 1
• Start date: June 2015
• Est. completion date: September 1, 2019

Study information

• Verified date: September 2019
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: September 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Complete resection was accepted in IIa ~ ?a 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.

Related Conditions & MeSH terms

• Lung Neoplasms
• Non-small Cell Lung Cancer(NSCLC)

Intervention

Drug:
• JinFuKang
po.tid.30ml
• Cisplatin
According to the individual patient's condition
• Pemetrexed
According to the individual patient's condition

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai University of Traditional Chinese Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival	It is decided by a doctor via the clinical examinations	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	Circulating Tumor Cell	It is decided by a doctor via the clinical examinations	24months
Secondary	Overall survival	It is decided by a doctor via the clinical examinations	Two years