Non-small Cell Lung CancerNCT06109454
Observation on the Therapeutic Effect of Huaier Granules in the Adjuvant Treatment of Non-small Cell Lung Cancer After Radical Surgery
An observational study of Non-small Cell Lung Cancer, run by Liaoning Cancer Hospital & Institute at 1 site in China.
Trial summary
This study is a multicenter, prospective, and observational clinical study aimed at exploring whether the 3-year DFS in the Huaier group is not inferior to the control group receiving standard platinum dual-drug chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Huaier granule
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 21 Mar 2024to Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: The study population is resectable stage Ⅱ-ⅢA non-small cell lung cancer patients.
Who may be able to join
- 18 years old ≤ age ≤ 75, regardless of gender.
- Confirmed as non-small cell lung cancer by histopathology, with pathological staging of stage Ⅱ-ⅢA.
- Received radical R0 resection of lung cancer within 2 months before enrollment, and did not receive any postoperative adjuvant therapy or preoperative neoadjuvant therapy.
- ECOG（Eastern Cooperative Oncology Group）score:0-2.
- The patient voluntarily participated in the study, agreed to cooperate with the researcher for data collection, and signed an informed consent form.
Who cannot join
- Known to be allergic to the components of Huaier granules or avoid or use Huaier granules with caution (Huaier group).
- Those who have difficulty swallowing, complete or incomplete gastrointestinal obstruction, active gastrointestinal bleeding, perforation, and other causes of difficulty in taking oral medication.
- Non-small cell lung cancer patients who plan to receive targeted therapy, immunotherapy, chemotherapy combined with immunotherapy, radiotherapy, synchronous radiotherapy and chemotherapy during the study period.
- The patient has a history of other new malignant tumors within 5 years.
- The expected survival time of the patient is less than half a year.
- Surgical complications that have not recovered or are accompanied by severe infections after radical resection of lung cancer.
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- Pregnant or lactating women or planned pregnancy preparation.
- The patient has received other traditional Chinese patent medicines and simple preparations with anti-tumor effect in the past one month (including but not limited to compound cantharidin capsule, cinobufagin capsule, Kangai injection, Brucea javanica injection, etc., the specific instructions shall prevail).
- The patient suffers from severe mental illness or other reasons that the researcher deems unsuitable to participate in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, 110801
Hongxu Liu, PhD, +8618040097698, hxliu@cmu.edu.cn
About this study
Official title: Observational Study on the Efficacy and Safety of Huaier Granules Compared With Platinum Containing Dual Drug Combination Chemotherapy in Adjuvant Therapy for Resectable Stage II-IIIA Non-small Cell Lung Cancer After Radical Surgery
This study is a multicenter, prospective, and observational clinical study aimed at exploring whether the 3-year DFS in the Huaier group is not inferior to the control group receiving standard platinum dual-drug chemotherapy.
Read the detailed description
This study is a small sample observational study, mainly exploring whether the 3-year DFS of the Huaier group is not inferior to the control group receiving standard platinum dual drug chemotherapy. Therefore, this study will conduct a small sample exploratory analysis. It is expected to include 240 non-small cell lung cancer patients who have been diagnosed with stage Ⅱ-ⅢA and are eligible for surgery at selected research centers from April 2023 to July 2025. Among them, 120 patients in the Huaier Granule group refused to undergo adjuvant chemotherapy due to reasons such as intolerance or disagreement, and agreed to receive Huaier Granule monotherapy as an adjuvant treatment; There are 120 patients in the control group, all of whom plan to receive standard chemotherapy as an adjuvant treatment plan (including platinum based dual-drug combination chemotherapy).
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Huaier granule, Control
- Keywords
- Huaier granule, Non-small Cell Lung Cancer, Efficacy, Safety
- 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
Also called Z20000109（NMPA Approval Number）
The subjects voluntarily gave up postoperative adjuvant therapy, including chemotherapy, targeted therapy, immunotherapy, and radiation therapy, and agreed to take Huaier granules.The subjects took Huaier granules orally, one bag (10g) per time, three times a day. Until the end of the study, intolerable toxicity, withdrawal from the study for any reason or death, or when the researcher determines that there is no further benefit, whichever occurs first. Please refer to the drug manual for specific usage. It is recommended that patients start taking Huaier granules 1-2 weeks after surgery.
ControlOther
The subjects received standard platinum dual drug chemotherapy.The subjects were treated with carboplatin injection (300mg/m2, intravenous injection, first day) combined with pemetrexed disodium (pathological type: adenocarcinoma, intravenous injection, 500mg/m2) or albumin bound paclitaxel (pathological type: squamous cell carcinoma, 260mg/m2, intravenous injection, first day) every three weeks, with a maximum of four cycles.
| Study group | Role | What they receive |
|---|---|---|
| Huaier Granule | The subjects voluntarily gave up postoperative adjuvant therapy, including chemotherapy, targeted therapy, immunotherapy, and radiation therapy, and agreed to take Huaier granules. Receives: Drug: Huaier granule | |
| Control | The subjects received standard platinum dual-drug chemotherapy. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year disease-free survival (DFS) rate
The proportion of participants who did not experience disease recurrence or death within 3 years after undergoing lung cancer radical surgery.
Measured: start of treatment until 3-year follow-up
Secondary outcomes (6)
1-year or 2-year DFS rate
The proportion of participants who did not experience disease recurrence or death within 1 or 2 years after undergoing lung cancer radical surgery
Measured: start of treatment until 1-year or 2-year follow-up
1-year, 2-year or 3-year overall survival (OS) rate
The proportion of subjects who survived within 1 year, 2 years or 3 years after undergoing radical lung cancer surgery among all subjects.
Measured: start of treatment until 1-year, 2-year or 3-year follow-up
1-year, 2-year or 3-year local recurrence free survival (LRFS) rates
The proportion of subjects who did not experience local recurrence of lung cancer within 1 year, 2 years or 3 years after undergoing radical lung cancer surgery.
Measured: start of treatment until 1-year, 2-year or 3-year follow-up
1-year, 2-year or 3-year distant metastasis free survival (DMFS) rates
The proportion of subjects who did not experience distant metastasis within 1 year, 2 years, or 3 years after undergoing lung cancer radical surgery
Measured: start of treatment until 1-year, 2-year or 3-year follow-up
Quality of Life Score (SF-36 Scale)
The Health Survey Short Form[(SF-36 Scale (Chinese Version) ]developed by the US Medical Bureau research team was used for evaluation. The scale has 36 items and aims to evaluate the health and functional status of multiple age groups, different diseases, and control populations.Note that all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.
Measured: start of treatment until 3-year follow-up
The incidence and severity of adverse events (AE) and severe adverse events (SAE)
The definitions and severity grading of AE and SAE can refer to the corresponding descriptions in the definition and evaluation section of AE. The incidence rate is defined as the proportion of subjects who have experienced AE and SAE to the corresponding total population.
Measured: start of treatment until 3-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start21 Mar 2024
- Primary completionSep 2025 (estimated)
- Study completionOct 2028 (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 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liaoning Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Collaborators
- LinkDoc Technology (Beijing) Co. Ltd., Huazhong University of Science and Technology
- Responsible party
- Principal investigator, Hongxu Liu, Liaoning Cancer Hospital & Institute
- Investigators
- Hongxu Liu, PhD, Principal investigator, Liaoning Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06109454
- Sponsor's protocol ID
- HE-202306
- Status last verified
- May 2024
- First submitted
- 24 Oct 2023
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on the Efficacy and Safety of Huaier Granules Compared With Platinum Containing Dual Drug Combination Chemotherapy in Adjuvant Therapy for Resectable Stage II-IIIA Non-small Cell Lung Cancer After Radical Surgery
- ClinicalTrials.gov ID
- NCT06109454
- Acronym / sponsor ID
- HE-202306
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Huaier granule, Non-small Cell Lung Cancer, Efficacy, Safety
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Liaoning Cancer Hospital & InstituteUniversity, hospital or other
- Collaborators
- LinkDoc Technology (Beijing) Co. Ltd., Huazhong University of Science and Technology
- Study start
- 21 Mar 2024 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 31 Oct 2023 (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 is a multicenter, prospective, and observational clinical study aimed at exploring whether the 3-year DFS in the Huaier group is not inferior to the control group receiving standard platinum dual-drug chemotherapy.
Detailed description
This study is a small sample observational study, mainly exploring whether the 3-year DFS of the Huaier group is not inferior to the control group receiving standard platinum dual drug chemotherapy. Therefore, this study will conduct a small sample exploratory analysis. It is expected to include 240 non-small cell lung cancer patients who have been diagnosed with stage Ⅱ-ⅢA and are eligible for surgery at selected research centers from April 2023 to July 2025. Among them, 120 patients in the Huaier Granule group refused to undergo adjuvant chemotherapy due to reasons such as intolerance or disagreement, and agreed to receive Huaier Granule monotherapy as an adjuvant treatment; There are 120 patients in the control group, all of whom plan to receive standard chemotherapy as an adjuvant treatment plan (including platinum based dual-drug combination chemotherapy).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Huaier Granule | – | Drug: Huaier granuleThe subjects voluntarily gave up postoperative adjuvant therapy, including chemotherapy, targeted therapy, immunotherapy, and radiation therapy, and agreed to take Huaier granules. |
| Control | – | Other: ControlThe subjects received standard platinum dual-drug chemotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is resectable stage Ⅱ-ⅢA non-small cell lung cancer patients.
Key inclusion criteria (5 listed)
- 18 years old ≤ age ≤ 75, regardless of gender.
- Confirmed as non-small cell lung cancer by histopathology, with pathological staging of stage Ⅱ-ⅢA.
- Received radical R0 resection of lung cancer within 2 months before enrollment, and did not receive any postoperative adjuvant therapy or preoperative neoadjuvant therapy.
- ECOG（Eastern Cooperative Oncology Group）score:0-2.
- The patient voluntarily participated in the study, agreed to cooperate with the researcher for data collection, and signed an informed consent form.
Key exclusion criteria (9 listed)
- Known to be allergic to the components of Huaier granules or avoid or use Huaier granules with caution (Huaier group).
- Those who have difficulty swallowing, complete or incomplete gastrointestinal obstruction, active gastrointestinal bleeding, perforation, and other causes of difficulty in taking oral medication.
- Non-small cell lung cancer patients who plan to receive targeted therapy, immunotherapy, chemotherapy combined with immunotherapy, radiotherapy, synchronous radiotherapy and chemotherapy during the study period.
- The patient has a history of other new malignant tumors within 5 years.
- The expected survival time of the patient is less than half a year.
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 granuleAlso: Z20000109（NMPA Approval Number）The subjects voluntarily gave up postoperative adjuvant therapy, including chemotherapy, targeted therapy, immunotherapy, and radiation therapy, and agreed to take Huaier granules.The subjects took Huaier granules orally, one bag (10g) per time, three times a day. Until the end of the study, intolerable toxicity, withdrawal from the study for any reason or death, or when the researcher determines that there is no further benefit, whichever occurs first. Please refer to the drug manual for specific usage. It is recommended that patients start taking Huaier granules 1-2 weeks after surgery. | Drug | Huaier Granule |
| ControlThe subjects received standard platinum dual drug chemotherapy.The subjects were treated with carboplatin injection (300mg/m2, intravenous injection, first day) combined with pemetrexed disodium (pathological type: adenocarcinoma, intravenous injection, 500mg/m2) or albumin bound paclitaxel (pathological type: squamous cell carcinoma, 260mg/m2, intravenous injection, first day) every three weeks, with a maximum of four cycles. | Other | Control |
Primary outcome
3-year disease-free survival (DFS) rate
Time frame: start of treatment until 3-year follow-up
The proportion of participants who did not experience disease recurrence or death within 3 years after undergoing lung cancer radical surgery.
6 secondary outcomes
1-year or 2-year DFS rate
Time frame: start of treatment until 1-year or 2-year follow-up
1-year, 2-year or 3-year overall survival (OS) rate
Time frame: start of treatment until 1-year, 2-year or 3-year follow-up
1-year, 2-year or 3-year local recurrence free survival (LRFS) rates
Time frame: start of treatment until 1-year, 2-year or 3-year follow-up
1-year, 2-year or 3-year distant metastasis free survival (DMFS) rates
Time frame: start of treatment until 1-year, 2-year or 3-year follow-up
Quality of Life Score (SF-36 Scale)
Time frame: start of treatment until 3-year follow-up
The incidence and severity of adverse events (AE) and severe adverse events (SAE)
Time frame: start of treatment until 3-year follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
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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.
Hongxu Liu, PhD principal investigator
Liaoning Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer, run by Liaoning Cancer Hospital & Institute 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 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: looking for participants now, as of the sponsor's last update on 10 May 2024. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hongxu Liu, PhD (+8618040097698, hxliu@cmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year disease-free survival (DFS) rate (time frame: start of treatment until 3-year follow-up). 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 10 May 2024.