Non-small Cell Lung Cancer (NSCLC)
Conditions
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
Interventions
DRUGGinsenoside H dripping pills
Experimental: 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.
DRUGGinsenoside H dripping pills+Placebo
Experimental: 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.
DRUGPlacebo
Placebo Comparator: Placebo. Dosage form:pill. Dosage :20pills ( only placebo ). Frequency:two times per day. Duration: until disease progression or death.
Sponsors
Tasly Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Pathologically or cytologically proven stage IIIB/IV NSCLC with a measurable lesions (including postoperative recurrence or metastasis) 2. 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. 3. The TCM Syndrome diagnosis of Qi-Deficiency. 4. Aged 18-75 years, both male and female. 5. ECOG performance status 0-2. 6. Expected to survive more than 3 months. 7. Joined in the test voluntarily and signed the Informed consent by GCP regulation.
Exclusion criteria
1. Liver and kidney damage(TBIL、ALT、AST is higher than the limit of normal value of 1.5 times, abnormal Cr). 2. Patients with significant cachexia. 3. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Symptoms scores of TCM | through study completion, an average of 1 year | 0 , every 4 weeks and the end of treatment |
| 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 |
| Overall Survival (OS) | through study completion, an average of 1 year | Evaluate overall survival (OS) in the 3 groups |
Other
| Measure | Time frame | Description |
|---|---|---|
| Hepatic function | through study completion, an average of 1 year | 0 , every 4 weeks during the period of 0 to 16 weeks, every 8 weeks after 16 weeks and the end of treatment |
| Urine routine test | through study completion, an average of 1 year | 0 , every 4 weeks during the period of 0 to 16 weeks, every 8 weeks after 16 weeks and the end of treatment |
| Blood routine test | through study completion, an average of 1 year | 0 , every 4 weeks during the period of 0 to 16 weeks, every 8 weeks after 16 weeks and the end of treatment |
Countries
China
Contacts
Primary ContactMin Zhao, PhD
Backup ContactNing Dai
Outcome results
None listed