A Study of Ginsenoside H Dripping Pills for Advanced Non-Small Cell Lung Cancer (NSCLC)

Non-small Cell Lung Cancer (NSCLC) Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02714608
• Other study ID #: TCM0319
• Status: Recruiting
• Phase: Phase 2
• First received: February 29, 2016
• Last updated: March 19, 2017
• Start date: May 2016
• Est. completion date: December 2018

Study information

• Verified date: March 2016
• Source: Tasly Pharmaceuticals, Inc.
• Contact: Min Zhao, PhD
• Phone: 008613820845180
• Email: zhaomin[@]tasly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: December 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer (NSCLC)

Intervention

Drug:
• Ginsenoside 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.
• Ginsenoside 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.
• Placebo
Placebo Comparator: Placebo. Dosage form:pill. Dosage :20pills ( only placebo ). Frequency:two times per day. Duration: until disease progression or death.

Locations

Country	Name	City	State
China	West China Hospital ,Sichuan University	Cheng Du	Sichuan
China	Guangdong Provincial Hospital of TCM	Guang Zhou	Guangdong
China	The First Affiliated Hospital of Guangzhou University of TCM	Guang Zhou	Guangdong
China	Hangzhou First People's Hospital	Hang Zhou	Zhejiang
China	Jiangsu Provincial Hospital of Integrated Chinese Traditional and Western Medicine	Nan Jing	Jiangsu
China	Jing'an District Centre Hospital of Shanghai	Shang Hai	Shanghai
China	Shuguang Hospital Affiliated with Shanghai University of TCM	Shang Hai	Shanghai
China	Tianjin People's Hospital	Tian Jin	Tianjin
China	The Second People's Hospital of Yibin	Yibin	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Tasly Pharmaceuticals, Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood routine test	0 , every 4 weeks during the period of 0 to 16 weeks, every 8 weeks after 16 weeks and the end of treatment	through study completion, an average of 1 year
Other	Urine routine test	0 , every 4 weeks during the period of 0 to 16 weeks, every 8 weeks after 16 weeks and the end of treatment	through study completion, an average of 1 year
Other	Hepatic function	0 , every 4 weeks during the period of 0 to 16 weeks, every 8 weeks after 16 weeks and the end of treatment	through study completion, an average of 1 year
Primary	Progression-free survival (PFS)	Evaluate progression free survival (PFS) in the 3 groups : 0 , every 8 weeks and the end of treatment	through study completion, an average of 1 year
Secondary	Overall Survival (OS)	Evaluate overall survival (OS) in the 3 groups	through study completion, an average of 1 year
Secondary	Time to progression(TTP)	Evaluate time to progression(TTP) in the 3 groups	through study completion, an average of 1 year
Secondary	Quality of Life	[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.	through study completion, an average of 1 year
Secondary	Symptoms scores of TCM	0 , every 4 weeks and the end of treatment	through study completion, an average of 1 year
Secondary	Cancer-related fatigue	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	through study completion, an average of 1 year