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

Primary Purpose

Non-small Cell Lung Cancer (NSCLC)

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Ginsenoside H dripping pills
Ginsenoside H dripping pills+Placebo
Placebo
Sponsored by
Tasly Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer (NSCLC)

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Ginsenoside H dripping pills

Ginsenoside H dripping pills+Placebo

Placebo

Arm Description

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.

Outcomes

Primary Outcome Measures

Progression-free survival (PFS)
Evaluate progression free survival (PFS) in the 3 groups : 0 , every 8 weeks and the end of treatment

Secondary Outcome Measures

Overall Survival (OS)
Evaluate overall survival (OS) in the 3 groups
Time to progression(TTP)
Evaluate time to progression(TTP) in the 3 groups
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.
Symptoms scores of TCM
0 , every 4 weeks and the end of treatment
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

Full Information

First Posted
February 29, 2016
Last Updated
March 19, 2017
Sponsor
Tasly Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02714608
Brief Title
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

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
May 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tasly Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer (NSCLC)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ginsenoside H dripping pills
Arm Type
Experimental
Arm Description
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.
Arm Title
Ginsenoside H dripping pills+Placebo
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Drug: Placebo. Dosage form:pill. Dosage :20pills ( only placebo ). Frequency:two times per day. Duration: until disease progression or death.
Intervention Type
Drug
Intervention Name(s)
Ginsenoside H dripping pills
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ginsenoside H dripping pills+Placebo
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo Comparator: Placebo. Dosage form:pill. Dosage :20pills ( only placebo ). Frequency:two times per day. Duration: until disease progression or death.
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
Evaluate progression free survival (PFS) in the 3 groups : 0 , every 8 weeks and the end of treatment
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
Evaluate overall survival (OS) in the 3 groups
Time Frame
through study completion, an average of 1 year
Title
Time to progression(TTP)
Description
Evaluate time to progression(TTP) in the 3 groups
Time Frame
through study completion, an average of 1 year
Title
Quality of Life
Description
[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.
Time Frame
through study completion, an average of 1 year
Title
Symptoms scores of TCM
Description
0 , every 4 weeks and the end of treatment
Time Frame
through study completion, an average of 1 year
Title
Cancer-related fatigue
Description
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
Time Frame
through study completion, an average of 1 year
Other Pre-specified Outcome Measures:
Title
Blood routine test
Description
0 , every 4 weeks during the period of 0 to 16 weeks, every 8 weeks after 16 weeks and the end of treatment
Time Frame
through study completion, an average of 1 year
Title
Urine routine test
Description
0 , every 4 weeks during the period of 0 to 16 weeks, every 8 weeks after 16 weeks and the end of treatment
Time Frame
through study completion, an average of 1 year
Title
Hepatic function
Description
0 , every 4 weeks during the period of 0 to 16 weeks, every 8 weeks after 16 weeks and the end of treatment
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min Zhao, PhD
Phone
008613820845180
Email
zhaomin@tasly.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ning Dai
Phone
008613612187689
Email
daining@tasly.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min Zhao, PhD
Organizational Affiliation
Tasly Group, Co. Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Guangdong Provincial Hospital of TCM
City
Guang Zhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wanyin Wu
Facility Name
The First Affiliated Hospital of Guangzhou University of TCM
City
Guang Zhou
State/Province
Guangdong
ZIP/Postal Code
510405
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lizhu Lin
Facility Name
Jiangsu Provincial Hospital of Integrated Chinese Traditional and Western Medicine
City
Nan Jing
State/Province
Jiangsu
ZIP/Postal Code
210028
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shibing Liao
Facility Name
Jing'an District Centre Hospital of Shanghai
City
Shang Hai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xueyong Wu
Facility Name
Shuguang Hospital Affiliated with Shanghai University of TCM
City
Shang Hai
State/Province
Shanghai
ZIP/Postal Code
201203
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qi Li
Facility Name
West China Hospital ,Sichuan University
City
Cheng Du
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Zhang
Facility Name
The Second People's Hospital of Yibin
City
Yibin
State/Province
Sichuan
ZIP/Postal Code
644000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuming Jia
Facility Name
Tianjin People's Hospital
City
Tian Jin
State/Province
Tianjin
ZIP/Postal Code
300000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiang Yao
Facility Name
Hangzhou First People's Hospital
City
Hang Zhou
State/Province
Zhejiang
ZIP/Postal Code
310002
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shengyou Lin

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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