the"Fuzheng" Therapy of TCM to Improve the Survival Quality of Early-stage NSCLC by Intervening the CTCs
CTC-TCM-FZ
A Study on the"Fuzheng"Therapy Promoted Immune Reconstitution to Improve the Survival of Early-stage Lung Cancer After Surgical Operation
3 other identifiers
interventional
218
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2015
Longer than P75 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 21, 2015
CompletedFirst Posted
Study publicly available on registry
November 11, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedSeptember 20, 2019
September 1, 2019
4.3 years
October 21, 2015
September 18, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Circulating Tumor Cell
24months
Overall survival
Two years
Study Arms (3)
Cisplatin
PLACEBO COMPARATORCisplatin
Pemetrexed
PLACEBO COMPARATORPemetrexed
Jinfukang
EXPERIMENTALJinfukang
Interventions
According to the individual patient's condition
According to the individual patient's condition
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
October 21, 2015
First Posted
November 11, 2015
Study Start
June 1, 2015
Primary Completion
September 1, 2019
Study Completion
September 1, 2019
Last Updated
September 20, 2019
Record last verified: 2019-09