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

• ClinicalTrials.gov Identifier: NCT02603003
• Recruitment Status: Completed
• First Posted: November 11, 2015
• Last Update Posted: September 20, 2019
• Sponsor: Shanghai University of Traditional Chinese Medicine
• Information provided by (Responsible Party): jianhuitian, Shanghai University of Traditional Chinese Medicine

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Non-small Cell Lung Cancer(NSCLC)	Drug: JinFuKang; Drug: Cisplatin; Drug: Pemetrexed	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 218 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Study on the"Fuzheng"Therapy Promoted Immune Reconstitution to Improve the Survival of Early-stage Lung Cancer After Surgical Operation
• Study Start Date: June 2015
• Actual Primary Completion Date: September 1, 2019
• Actual Study Completion Date: September 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: jianhuitian, Clinical Professor, Shanghai University of Traditional Chinese Medicine
• ClinicalTrials.gov Identifier: NCT02603003
• Other Study ID Numbers: Longhua Hospital; TJH20151021 ( Registry Identifier: TIAN Jianhui ); LB20151106 ( Registry Identifier: Robin )
• First Posted: November 11, 2015
• Last Update Posted: September 20, 2019
• Last Verified: September 2019

Keywords provided by jianhuitian, Shanghai University of Traditional Chinese Medicine:

Circulating tumor cells(CTCs); Traditional Chinese Medicine(TCM); Myeloid-derived suppressor cells(MDSCs)

Additional relevant MeSH terms:

Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pemetrexed; Antineoplastic Agents; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors