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Completed

NCT Number: NCT02603003

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

JinFuKang

Drug

po.tid.30ml

Other names: Jin Fukang oral liquid

Cisplatin

Drug

According to the individual patient's condition

Other names: Navelbine

Pemetrexed

Drug

According to the individual patient's condition

Other names: Pemetrexeddisodium for Injection

Primary outcomes

  1. 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 outcomes

  1. Circulating Tumor Cell

    Time frame: 24months

    It is decided by a doctor via the clinical examinations

  2. Overall survival

    Time frame: Two years

    It is decided by a doctor via the clinical examinations

Sponsors and collaborators

Lead sponsor

Shanghai University of Traditional Chinese Medicine

Other

Registry information

Official study title

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

Acronym: CTC-TCM-FZ

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Nov 11, 2015
Registry last updated
Sep 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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