A Study of Ginsenoside H Dripping Pills for Advanced Non-Small Cell Lung Cancer (NSCLC)
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Interventions
- Registration Number
- NCT02714608
- Lead Sponsor
- Tasly Pharmaceuticals, Inc.
- Brief Summary
Ginsenoside H dripping pills is a kind of traditional Chinese medicine(TCM), This study is being conducted to evaluate the efficacy and safety of ginsenoside H dripping pills in patients with advanced (stage ⅢB/Ⅳ) Non-small Cell Lung Cancer (Syndrome Of Qi-Deficiency) and explore the optimal dosage
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 144
- 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.
- 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.
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Participated in other clinical trial within 3 months.
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Treated by chemotherapy, radiotherapy or targeted therapy within 4 weeks.
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Possible to be treated by chemotherapy, radiotherapy or targeted therapy during the study.
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Not fit for the clinical trial judged by the investigator.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ginsenoside H dripping pills+Placebo Ginsenoside H dripping pills+Placebo 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. Ginsenoside H dripping pills Ginsenoside H dripping pills 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. Placebo Placebo Drug: Placebo. Dosage form:pill. Dosage :20pills ( only placebo ). Frequency:two times per day. Duration: until disease progression or death.
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS) through study completion, an average of 1 year Evaluate progression free survival (PFS) in the 3 groups : 0 , every 8 weeks and the end of treatment
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) through study completion, an average of 1 year Evaluate overall survival (OS) in the 3 groups
Symptoms scores of TCM through study completion, an average of 1 year 0 , every 4 weeks and the end of treatment
Time to progression(TTP) through study completion, an average of 1 year Evaluate time to progression(TTP) in the 3 groups
Quality of Life through study completion, an average of 1 year \[0 , every 4 weeks and the end of treatment\] To determine the quality of life by using the European Organisation of Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) scales.
Cancer-related fatigue through study completion, an average of 1 year Evaluate the fatigue degree in the 3 groups using the Chinese version of Brief Fatigue Index (BFI-C): 0 , every 4 weeks and the end of treatment
Trial Locations
- Locations (9)
Jing'an District Centre Hospital of Shanghai
🇨🇳Shang Hai, Shanghai, China
Guangdong Provincial Hospital of TCM
🇨🇳Guang Zhou, Guangdong, China
Jiangsu Provincial Hospital of Integrated Chinese Traditional and Western Medicine
🇨🇳Nan Jing, Jiangsu, China
Shuguang Hospital Affiliated with Shanghai University of TCM
🇨🇳Shang Hai, Shanghai, China
West China Hospital ,Sichuan University
🇨🇳Cheng Du, Sichuan, China
The Second People's Hospital of Yibin
🇨🇳Yibin, Sichuan, China
The First Affiliated Hospital of Guangzhou University of TCM
🇨🇳Guang Zhou, Guangdong, China
Tianjin People's Hospital
🇨🇳Tian Jin, Tianjin, China
Hangzhou First People's Hospital
🇨🇳Hang Zhou, Zhejiang, China