Non-small Cell Lung CancerNCT03198117
Huaier Granule for Prevention of Recurrence and Metastasis of Stage II and III Non-small Cell Lung Cancer (NSCLC)
A study testing Huaier Granule in people with Non-small Cell Lung Cancer, run by Qidong Gaitianli Medicines Co., Ltd at 1 site in China.
Trial summary
This study including two parts，one part is a randomized clinical trial design，another part is a registration study. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Huaier Granule
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 25 Apr 2017to 23 Nov 2017
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with complete resection who are at TNM (primary tumor, regional nodes, metastasis) stage II-Ⅲa, postoperative pathology confirmed for non-small cell lung cancer;
- Has completed four cycle standard solution of adjuvant chemotherapy, or refused to accept the postoperative adjuvant chemotherapy;
- Patients between 18 and 70 years old, no gender restriction;
- Eastern Cooperative Oncology Group (ECOG) PS of two or less;
- Before the start of the study, patient fully understands the study and is willing to sign the informed consent form;
Who cannot join
- Receiving adjuvant chemotherapy patients started greater than 24 weeks from surgical resection;
- Refused adjuvant chemotherapy patients started greater than 8 weeks from surgical resection;
- Suspected malignant pleural effusion;
- There is no clear pathological diagnosis;
- Combined with other cancer;
- Patient have a positive surgical margin;
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- Accept other treatment for lung cancer of postoperative；
- Combined with severe idiopathic disease of liver, kidney and hematopoietic system;
- Combined psychosis or AIDS;
- Allergy to the test drug;
- Pregnant or lactating women;
- Participation in any other clinical trial within three months;
- Conditions that are considered not suitable for this study investigators.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Huaier Granule for Prevention of Recurrence and Metastasis of Stage II and III NSCLC After Postoperative Adjuvant Chemotherapy: A Multicenter Randomized, Double-blind, Placebo-controlled Clinical Trial, Along With a Registration Study
This study including two parts，one part is a randomized clinical trial design，another part is a registration study.
Read the detailed description
This study include a multicenter, randomized, controlled, double-blind, placebo-controlled post-market clinical trial and a registration study.
The randomized clinical trial included subjects (n =798) will be randomly divided into experimental (n = 532) and control groups (n =266) according to a random number table. Patients in the experimental group will receive Huaier Granule (20g/time, 3 times/d). Patients in the control group will receive placebo (20g/time, 3 times/d). The registration study plan to recruitment at least 300 patients.
The primary outcome measures is disease-free survival，secondary outcome measures is 2-year overall survivals, ECOG-performance status, Karnofsky performance score and tumor markers (CEA、CYFRA21-1、SCC).
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Huaier Granule, 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.
Huaier GranuleDrug
a Chinese traditional medicine
placeboOther
placebo
| Study group | Role | What they receive |
|---|---|---|
| Huaier Granule | Experimental | Huaier Granule Receives: Drug: Huaier Granule |
| placebo | Placebo comparator | placebo Receives: Other: placebo |
| No-treatment Control | No intervention | patients refused any treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease-free survival
disease-free survival
Measured: 2-year
Secondary outcomes (7)
overall survivals
overall survivals
Measured: 2-year
Quality of Life
Quality of Life-EORTC QLQ-C30
Measured: 2-year
KPS
Karnofsky
Measured: 2-year
ECOG-PS
ECOG-PS
Measured: 2-year
CEA
tumor markers
Measured: 2-year
CYFRA21-1
tumor markers
Measured: 2-year
SCC
tumor markers
Measured: 2-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study start25 Apr 2017
- Primary completion23 Nov 2017
- Study completion23 Nov 2017
Why it stopped: Difficulty in patient recruitment
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 CancerStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qidong Gaitianli Medicines Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- guoping sun, doctor, Principal investigator, The First Affiliated Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03198117
- Sponsor's protocol ID
- HE-201701
- Status last verified
- Mar 2020
- First submitted
- 31 May 2017
- Last updated
- 9 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Huaier Granule for Prevention of Recurrence and Metastasis of Stage II and III NSCLC After Postoperative Adjuvant Chemotherapy: A Multicenter Randomized, Double-blind, Placebo-controlled Clinical Trial, Along With a Registration Study
- ClinicalTrials.gov ID
- NCT03198117
- Acronym / sponsor ID
- HE-201701
- Conditions
- Non-small Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in patient recruitment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Qidong Gaitianli Medicines Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 25 Apr 2017 (actual)
- Primary completion
- 23 Nov 2017 (actual)
- Study completion
- 23 Nov 2017 (actual)
- First posted
- 23 Jun 2017 (actual)
- 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.
This study including two parts，one part is a randomized clinical trial design，another part is a registration study.
Detailed description
This study include a multicenter, randomized, controlled, double-blind, placebo-controlled post-market clinical trial and a registration study.
The randomized clinical trial included subjects (n =798) will be randomly divided into experimental (n = 532) and control groups (n =266) according to a random number table. Patients in the experimental group will receive Huaier Granule (20g/time, 3 times/d). Patients in the control group will receive placebo (20g/time, 3 times/d). The registration study plan to recruitment at least 300 patients.
The primary outcome measures is disease-free survival，secondary outcome measures is 2-year overall survivals, ECOG-performance status, Karnofsky performance score and tumor markers (CEA、CYFRA21-1、SCC).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Huaier Granule | Experimental | Drug: Huaier GranuleHuaier Granule |
| placebo | Placebo comparator | Other: placeboplacebo |
| No-treatment Control | No intervention | –patients refused any treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with complete resection who are at TNM (primary tumor, regional nodes, metastasis) stage II-Ⅲa, postoperative pathology confirmed for non-small cell lung cancer;
- Has completed four cycle standard solution of adjuvant chemotherapy, or refused to accept the postoperative adjuvant chemotherapy;
- Patients between 18 and 70 years old, no gender restriction;
- Eastern Cooperative Oncology Group (ECOG) PS of two or less;
- Before the start of the study, patient fully understands the study and is willing to sign the informed consent form;
Key exclusion criteria (13 listed)
- Receiving adjuvant chemotherapy patients started greater than 24 weeks from surgical resection;
- Refused adjuvant chemotherapy patients started greater than 8 weeks from surgical resection;
- Suspected malignant pleural effusion;
- There is no clear pathological diagnosis;
- Combined with other cancer;
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 |
|---|---|---|
| Huaier Granulea Chinese traditional medicine | Drug | Huaier Granule |
| placeboplacebo | Other | placebo |
Primary outcome
disease-free survival
Time frame: 2-year
disease-free survival
7 secondary outcomes
overall survivals
Time frame: 2-year
Quality of Life
Time frame: 2-year
KPS
Time frame: 2-year
ECOG-PS
Time frame: 2-year
CEA
Time frame: 2-year
CYFRA21-1
Time frame: 2-year
SCC
Time frame: 2-year
Results and safety
The study was stopped early (reason given: Difficulty in patient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2020.
- 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.
guoping sun, doctor principal investigator
The First Affiliated Hospital of Anhui Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Huaier Granule in people with Non-small Cell Lung Cancer, run by Qidong Gaitianli Medicines Co., Ltd at 1 site 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 5 inclusion and 13 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: stopped early, as of the sponsor's last update on 9 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study was stopped early (reason given: Difficulty in patient recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease-free survival (time frame: 2-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 9 Mar 2020.