Non-small Cell Lung Cancer (NSCLC)Phase 2NCT02714608
A Study of Ginsenoside H Dripping Pills for Advanced Non-Small Cell Lung Cancer (NSCLC)
A Phase 2 study testing Ginsenoside H dripping pills in people with Non-small Cell Lung Cancer (NSCLC), run by Tasly Pharmaceuticals, Inc. at 9 sites in China.
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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer (NSCLC)
- What is being tested?
- Ginsenoside H dripping pills
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 9 sitesChina
- Study dates
- May 2016to Dec 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites, 9 recruiting
- Recruiting
West China Hospital ,Sichuan University
Chengdu, Sichuan, 610041
Ying Zhang
- Not yet recruiting
Guangdong Provincial Hospital of TCM
Guangzhou, Guangdong, 510120
Wanyin Wu
- Recruiting
The First Affiliated Hospital of Guangzhou University of TCM
Guangzhou, Guangdong, 510405
Lizhu Lin
- Not yet recruiting
Hangzhou First People's Hospital
Hangzhou, Zhejiang, 310002
Shengyou Lin
- Recruiting
Jiangsu Provincial Hospital of Integrated Chinese Traditional and Western Medicine
Nanjing, Jiangsu, 210028
Shibing Liao
- Not yet recruiting
Jing'an District Centre Hospital of Shanghai
Shanghai, Shanghai Municipality, 200040
Xueyong Wu
- Recruiting
Shuguang Hospital Affiliated with Shanghai University of TCM
Shanghai, Shanghai Municipality, 201203
Qi Li
- Recruiting
Tianjin People's Hospital
Tianjin, Tianjin Municipality, 300000
Qiang Yao
- Not yet recruiting
The Second People's Hospital of Yibin
Yibin, Sichuan, 644000
Yuming Jia
About this study
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)
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
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Being tested
- Ginsenoside H dripping pills, Ginsenoside H dripping pills+Placebo, Placebo
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ginsenoside H dripping pillsDrug
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+PlaceboDrug
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.
PlaceboDrug
Placebo Comparator: Placebo. Dosage form:pill. Dosage :20pills ( only placebo ). Frequency:two times per day. Duration: until disease progression or death.
| Study group | Role | What they receive |
|---|---|---|
| Ginsenoside H dripping pills | Experimental | 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. Receives: Drug: Ginsenoside H dripping pills |
| 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. Receives: Drug: Ginsenoside H dripping pills+Placebo |
| Placebo | Placebo comparator | Drug: Placebo. Dosage form:pill. Dosage :20pills ( only placebo ). Frequency:two times per day. Duration: until disease progression or death. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Evaluate progression free survival (PFS) in the 3 groups : 0 , every 8 weeks and the end of treatment
Measured: through study completion, an average of 1 year
Secondary outcomes (5)
Overall Survival (OS)
Evaluate overall survival (OS) in the 3 groups
Measured: through study completion, an average of 1 year
Time to progression(TTP)
Evaluate time to progression(TTP) in the 3 groups
Measured: through study completion, an average of 1 year
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.
Measured: through study completion, an average of 1 year
Symptoms scores of TCM
0 , every 4 weeks and the end of treatment
Measured: through study completion, an average of 1 year
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
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tasly Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Min Zhao, PhD, Study director, Tasly Group, Co. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02714608
- Sponsor's protocol ID
- TCM0319
- Status last verified
- Mar 2016
- First submitted
- 29 Feb 2016
- Last updated
- 21 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02714608
- Acronym / sponsor ID
- TCM0319
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Tasly Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2016
- Primary completion
- May 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 21 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ginsenoside H dripping pills | Experimental | Drug: Ginsenoside H dripping pillsDrug: 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+PlaceboDrug: 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 | Drug: PlaceboDrug: Placebo. Dosage form:pill. Dosage :20pills ( only placebo ). Frequency:two times per day. Duration: until disease progression or death. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ginsenoside H dripping pillsExperimental: 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 |
| Ginsenoside H dripping pills+PlaceboExperimental: 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 |
| PlaceboPlacebo Comparator: Placebo. Dosage form:pill. Dosage :20pills ( only placebo ). Frequency:two times per day. Duration: until disease progression or death. | Drug | Placebo |
Primary outcome
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
5 secondary outcomes
Overall Survival (OS)
Time frame: through study completion, an average of 1 year
Time to progression(TTP)
Time frame: through study completion, an average of 1 year
Quality of Life
Time frame: through study completion, an average of 1 year
Symptoms scores of TCM
Time frame: through study completion, an average of 1 year
Cancer-related fatigue
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min Zhao, PhD study director
Tasly Group, Co. Ltd.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ginsenoside H dripping pills in people with Non-small Cell Lung Cancer (NSCLC), run by Tasly Pharmaceuticals, Inc. at 9 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min Zhao, PhD (008613820845180, zhaomin@tasly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2017.