Overview

This trial is active, not recruiting.

Condition non-small cell lung cancer(nsclc)
Treatments jinfukang, cisplatin, pemetrexed
Phase phase 1
Sponsor Shanghai University of Traditional Chinese Medicine
Start date June 2015
End date June 2018
Trial size 200 participants
Trial identifier NCT02603003, LB20151106, Longhua Hospital, TJH20151021

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Placebo Comparator)
Cisplatin
cisplatin Navelbine
According to the individual patient's condition
(Placebo Comparator)
Pemetrexed
pemetrexed Pemetrexeddisodium for Injection
According to the individual patient's condition
(Experimental)
Jinfukang
jinfukang Jin Fukang oral liquid
po.tid.30ml
cisplatin Navelbine
According to the individual patient's condition
pemetrexed Pemetrexeddisodium for Injection
According to the individual patient's condition

Primary Outcomes

Measure
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.

Secondary Outcomes

Measure
Circulating Tumor Cell
time frame: 24months
Overall survival
time frame: Two years

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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.

Additional Information

Official title A Study on the"Fuzzing"Therapy Promoted Immune Reconstitution to Improve the Survival of Early-stage Lung Cancer After Surgical Operation
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Shanghai University of Traditional Chinese Medicine.