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

Shanghai University of Traditional Chinese Medicine

Status and phase: Completed; Phase 1

Conditions: Non-small Cell Lung Cancer(NSCLC)

Treatments: Drug: Pemetrexed; Drug: Cisplatin; Drug: JinFuKang

Study type: Interventional

Funder types: Other

Identifiers

NCT02603003

TJH20151021 (Registry Identifier)

LB20151106 (Registry Identifier)

Longhua Hospital

Details and patient eligibility

About

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.

Full 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.

Enrollment: 218 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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218 participants in 3 patient groups, including a placebo group

Cisplatin

Placebo Comparator group

Description:

Cisplatin

Treatment:

Drug: Cisplatin

Pemetrexed

Placebo Comparator group

Description:

Pemetrexed

Treatment:

Drug: Pemetrexed

Jinfukang

Experimental group

Description:

Jinfukang

Treatment:

Drug: JinFuKang

Drug: Cisplatin

Drug: Pemetrexed