Clinical trial NCT02714608: A Study of Ginsenoside H Dripping Pills for Advanced Non-Small Cell Lung Cancer (NSCLC)
Official title: A PhaseⅡa, Placebo Parallel Control, Central Randomized, Double Blind, Dosage Exploring and Multi-Center Study to Evaluate the Efficacy and Safety of Ginsenoside H Dripping Pills in Patients With Advanced NSCLC (Syndrome Of Qi-Deficiency)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer (NSCLC)
Lead sponsor: Tasly Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2016-03-21
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: through study completion, an average of 1 year
measure: Time to progression(TTP)
timeFrame: through study completion, an average of 1 year
measure: Quality of Life
timeFrame: through study completion, an average of 1 year
measure: Symptoms scores of TCM
timeFrame: through study completion, an average of 1 year
measure: Cancer-related fatigue
timeFrame: through study completion, an average of 1 year
Other outcomes:
measure: Blood routine test
timeFrame: through study completion, an average of 1 year
measure: Urine routine test
timeFrame: through study completion, an average of 1 year
measure: Hepatic function
timeFrame: through study completion, an average of 1 year
Locations:
city: Guang Zhou
country: China
facility: Guangdong Provincial Hospital of TCM
state: Guangdong
city: Guang Zhou
country: China
facility: The First Affiliated Hospital of Guangzhou University of TCM
state: Guangdong
city: Nan Jing
country: China
facility: Jiangsu Provincial Hospital of Integrated Chinese Traditional and Western Medicine
state: Jiangsu
city: Shang Hai
country: China
facility: Jing'an District Centre Hospital of Shanghai
state: Shanghai
city: Shang Hai
country: China
facility: Shuguang Hospital Affiliated with Shanghai University of TCM
state: Shanghai
city: Cheng Du
country: China
facility: West China Hospital ,Sichuan University
state: Sichuan
city: Yibin
country: China
facility: The Second People's Hospital of Yibin
state: Sichuan
city: Tian Jin
country: China
facility: Tianjin People's Hospital
state: Tianjin
city: Hang Zhou
country: China
facility: Hangzhou First People's Hospital
state: Zhejiang
Study officials:
affiliation: Tasly Group, Co. Ltd.
name: Min Zhao, PhD
role: STUDY_DIRECTOR
References: