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

September 18, 2019 updated by: jianhuitian, Shanghai University of Traditional Chinese Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

218

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Cisplatin
Drug: Cisplatin
According to the individual patient's condition
Other Names:
  • Navelbine
Placebo Comparator: Pemetrexed
Drug: Pemetrexed
According to the individual patient's condition
Other Names:
  • Pemetrexeddisodium for Injection
Experimental: Jinfukang
Drug: Cisplatin
According to the individual patient's condition
Other Names:
  • Navelbine
Drug: Pemetrexed
According to the individual patient's condition
Other Names:
  • Pemetrexeddisodium for Injection
Drug: JinFuKang
po.tid.30ml
Other Names:
  • Jin Fukang oral liquid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Circulating Tumor Cell
Time Frame: 24months
It is decided by a doctor via the clinical examinations
24months
Overall survival
Time Frame: Two years
It is decided by a doctor via the clinical examinations
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai University of Traditional Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

September 1, 2019

Study Completion (Actual)

September 1, 2019

Study Registration Dates

First Submitted

October 21, 2015

First Submitted That Met QC Criteria

November 10, 2015

First Posted (Estimate)

November 11, 2015

Study Record Updates

Last Update Posted (Actual)

September 20, 2019

Last Update Submitted That Met QC Criteria

September 18, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Longhua Hospital
  • TJH20151021 (Registry Identifier: TIAN Jianhui)
  • LB20151106 (Registry Identifier: Robin)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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