A Study of Ginsenoside H Dripping Pills for Advanced Non-Small Cell Lung Cancer (NSCLC)
Non-small Cell Lung Cancer (NSCLC)
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer (NSCLC)
Eligibility Criteria
Inclusion Criteria:
- Pathologically or cytologically proven stage IIIB/IV NSCLC with a measurable lesions (including postoperative recurrence or metastasis)
- The patients who can not be treated by surgical resection, conventional radiotherapy and chemotherapy or molecular targeted drugs treatment failure, not willing to accept, or intolerance to radiotherapy and chemotherapy or molecular targeted therapy.
- The TCM Syndrome diagnosis of Qi-Deficiency.
- Aged 18-75 years, both male and female.
- ECOG performance status 0-2.
- Expected to survive more than 3 months.
- Joined in the test voluntarily and signed the Informed consent by GCP regulation.
Exclusion Criteria:
- Liver and kidney damage(TBIL、ALT、AST is higher than the limit of normal value of 1.5 times, abnormal Cr).
- Patients with significant cachexia.
- Untreated symptomatic brain metastases.
4 .Allergic constitution, or for a variety of drug allergy.
5 .Combined with severe cardiovascular, hepatic, renal disease , pregnancy or breast-feeding women, psychopath.
6. Participated in other clinical trial within 3 months.
7. Treated by chemotherapy, radiotherapy or targeted therapy within 4 weeks.
8. Possible to be treated by chemotherapy, radiotherapy or targeted therapy during the study.
9. Not fit for the clinical trial judged by the investigator.
Sites / Locations
- Guangdong Provincial Hospital of TCM
- The First Affiliated Hospital of Guangzhou University of TCMRecruiting
- Jiangsu Provincial Hospital of Integrated Chinese Traditional and Western MedicineRecruiting
- Jing'an District Centre Hospital of Shanghai
- Shuguang Hospital Affiliated with Shanghai University of TCMRecruiting
- West China Hospital ,Sichuan UniversityRecruiting
- The Second People's Hospital of Yibin
- Tianjin People's HospitalRecruiting
- Hangzhou First People's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Ginsenoside H dripping pills
Ginsenoside H dripping pills+Placebo
Placebo
Drug: Ginsenoside H dripping pills. Dosage form:pill. Dosage :20pills ( only ginsenoside H dripping pills). Frequency:two times per day. Duration: until disease progression or death.
Drug: Ginsenoside H dripping pills ,Placebo. Dosage form:pill. Dosage :20pills ( ginsenoside H dripping pills 10 pills and placebo 10 pills). Frequency:two times per day. Duration: until disease progression or death.
Drug: Placebo. Dosage form:pill. Dosage :20pills ( only placebo ). Frequency:two times per day. Duration: until disease progression or death.