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

March 19, 2017 updated by: Tasly Pharmaceuticals, Inc.

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)

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

144

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guang Zhou, Guangdong, China, 510120
        • Not yet recruiting
        • Guangdong Provincial Hospital of TCM
        • Contact:
          • Wanyin Wu
      • Guang Zhou, Guangdong, China, 510405
        • Recruiting
        • The First Affiliated Hospital of Guangzhou University of TCM
        • Contact:
          • LIzhu Lin
    • Jiangsu
      • Nan Jing, Jiangsu, China, 210028
        • Recruiting
        • Jiangsu Provincial Hospital of Integrated Chinese Traditional and Western Medicine
        • Contact:
          • Shibing Liao
    • Shanghai
      • Shang Hai, Shanghai, China, 200040
        • Not yet recruiting
        • Jing'an District Centre Hospital of Shanghai
        • Contact:
          • Xueyong Wu
      • Shang Hai, Shanghai, China, 201203
        • Recruiting
        • Shuguang Hospital Affiliated with Shanghai University of TCM
        • Contact:
          • Qi Li
    • Sichuan
      • Cheng Du, Sichuan, China, 610041
        • Recruiting
        • West China Hospital ,Sichuan University
        • Contact:
          • Ying Zhang
      • Yibin, Sichuan, China, 644000
        • Not yet recruiting
        • The Second People's Hospital of Yibin
        • Contact:
          • Yuming Jia
    • Tianjin
      • Tian Jin, Tianjin, China, 300000
        • Recruiting
        • Tianjin People's Hospital
        • Contact:
          • Qiang Yao
    • Zhejiang
      • Hang Zhou, Zhejiang, China, 310002
        • Not yet recruiting
        • Hangzhou First People's Hospital
        • Contact:
          • Shengyou Lin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Experimental: 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.
Drug: 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 Comparator: Placebo
Drug: Placebo. Dosage form:pill. Dosage :20pills ( only placebo ). Frequency:two times per day. Duration: until disease progression or death.
Drug: Placebo
Placebo Comparator: Placebo. Dosage form:pill. Dosage :20pills ( only placebo ). Frequency:two times per day. Duration: until disease progression or death.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: 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
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: through study completion, an average of 1 year
Evaluate overall survival (OS) in the 3 groups
through study completion, an average of 1 year
Time to progression(TTP)
Time Frame: through study completion, an average of 1 year
Evaluate time to progression(TTP) in the 3 groups
through study completion, an average of 1 year
Quality of Life
Time Frame: 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.
through study completion, an average of 1 year
Symptoms scores of TCM
Time Frame: through study completion, an average of 1 year
0 , every 4 weeks and the end of treatment
through study completion, an average of 1 year
Cancer-related fatigue
Time Frame: 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
through study completion, an average of 1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood routine test
Time Frame: 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
through study completion, an average of 1 year
Urine routine test
Time Frame: 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
through study completion, an average of 1 year
Hepatic function
Time Frame: 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
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tasly Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

May 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

February 29, 2016

First Submitted That Met QC Criteria

March 15, 2016

First Posted (Estimate)

March 21, 2016

Study Record Updates

Last Update Posted (Actual)

March 21, 2017

Last Update Submitted That Met QC Criteria

March 19, 2017

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCM0319

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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