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

Phase 1

Completed

• Conditions: Non-small Cell Lung Cancer(NSCLC)
• Interventions: Drug: JinFuKang; Drug: Cisplatin; Drug: Pemetrexed

• Registration Number: NCT02603003
• Lead Sponsor: Shanghai University of Traditional Chinese Medicine

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-10-21
• Study First Submitted QC: 2015-11-10
• Study First Posted: 2015-11-11
• Status Verified: 2019-09
• Primary Completion: 2019-09-01
• Study Completion: 2019-09-01
• Last Update Submitted: 2019-09-18
• Last Update Posted: 2019-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 218

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Jinfukang	JinFuKang	Jinfukang
Jinfukang	Pemetrexed	Jinfukang
Pemetrexed	Pemetrexed	Pemetrexed
Cisplatin	Cisplatin	Cisplatin
Jinfukang	Cisplatin	Jinfukang

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival	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

Name	Time	Method
Overall survival	Two years	It is decided by a doctor via the clinical examinations
Circulating Tumor Cell	24months	It is decided by a doctor via the clinical examinations