Non-small Cell Lung Cancer (NSCLC)Phase 3HAMSTERNCT07197853
Clinical Efficacy and Safety of Microwave Ablation Combined With Huaier Granules in Patients With Inoperable Stage IA Non-Small Cell Lung Cancer: A Prospective, Single-Center, Randomized Controlled Clinical Trial
A Phase 3 study testing Huaier Granule in people with Non-small Cell Lung Cancer (NSCLC) and Huaier Granules, run by Xin Ye.
Trial summary
This prospective, single-center, randomized controlled clinical trial aims to evaluate the efficacy and safety of microwave ablation (MWA) combined with Huaier granules in patients with inoperable stage IA non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-small Cell Lung Cancer (NSCLC), Huaier Granules, Microwave Ablation
- What is being tested?
- Huaier Granule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 30 Jun 2028
- Phase
- Phase 3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age:
- ≥ 18 years old.
- Diagnosis:
- Histologically or cytologically confirmed IA stage non-small cell lung cancer (NSCLC) that is inoperable.
- ECOG Performance Status:
- 0-2 (Eastern Cooperative Oncology Group performance status).
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- Previous Treatment:
- Patients must have received no prior systemic treatment for lung cancer.
- Informed Consent:
- Ability to provide written informed consent and willingness to comply with study requirements.
- Adequate Organ Function:
- Patients must have adequate hepatic, renal, and hematologic function as evidenced by:
- Bilirubin ≤ 1.5 × upper limit of normal (ULN)
- ALT/AST ≤ 2.5 × ULN
- Creatinine clearance ≥ 30 mL/min
- Absolute neutrophil count (ANC) ≥ 1,500 cells/μL
Who cannot join
- Other Malignancies:
- Active or history of other malignancies within the past 5 years, except for non-melanoma skin cancer or in situ carcinoma.
- Severe Concurrent Diseases:
- Any serious or uncontrolled medical condition such as:
- Cardiovascular disease (e.g., recent myocardial infarction, unstable angina, or severe arrhythmia)
- Uncontrolled diabetes or hypertension
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- Active infections requiring systemic antibiotics or antivirals
- Pregnancy or Breastfeeding:
- Women who are pregnant, breastfeeding, or planning to become pregnant during the study.
- Immunosuppressive Therapy:
- Patients who have received immunosuppressive therapy within 30 days prior to enrollment.
- Other Contraindications:
- Known hypersensitivity to any of the components of the treatment regimen (e.g., microwave ablation, Huai Er Granules).
- Other Unspecified Conditions:
- Any other condition or circumstances that, in the investigator's opinion, may interfere with the study or pose a risk to the patient.
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Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Single-Center, Randomized Controlled Trial to Evaluate the Clinical Efficacy and Safety of Microwave Ablation Combined With Huaier Granules in Patients With Stage IA Non-Small Cell Lung Cancer
This prospective, single-center, randomized controlled clinical trial aims to evaluate the efficacy and safety of microwave ablation (MWA) combined with Huaier granules in patients with inoperable stage IA non-small cell lung cancer (NSCLC). A total of 180 eligible patients will be randomly assigned to receive either MWA alone or MWA combined with Huaier granules. The primary endpoint is progression-free survival (PFS) assessed by RECIST 1.1 criteria. Secondary outcomes include local progression rate (LPR), overall survival (OS), tumor markers, immune function, and quality of life. Safety will be evaluated using the CTCAE v5.0 criteria. The study seeks to determine whether the combined therapy offers improved tumor control and immune benefits over MWA alone.
Read the detailed description
Lung cancer remains the leading cause of cancer-related death globally, with non-small cell lung cancer (NSCLC) accounting for approximately 85% of cases. A significant proportion of early-stage NSCLC patients are deemed inoperable due to comorbidities or patient refusal. Microwave ablation (MWA) is an established local therapy for inoperable NSCLC, yet incomplete ablation and immune suppression in the tumor microenvironment remain challenges, especially in tumors >3 cm or near critical structures.
This study investigates whether the addition of Huaier granules, a polysaccharide-based traditional Chinese medicine shown to modulate immune function and improve outcomes post-ablation in liver cancer, can enhance the efficacy of MWA in early-stage NSCLC. Huaier may promote dendritic cell maturation, Th1 immune responses, and restore immune balance after incomplete MWA (iMWA).
Eligible patients (stage IA-IIA NSCLC without lymph node metastasis, ECOG ≤2, life expectancy >3 months) will be randomized 1:1 into two groups. The experimental group will receive CT-guided MWA followed by oral Huaier granules (10 g three times daily for 72 weeks), while the control group receives MWA alone. Follow-up will occur at months 1, 3, 6, 12, and 24.
Primary endpoint: progression-free survival (PFS). Secondary endpoints: local progression rate (LPR), overall survival (OS), immune cell profiles, tumor markers (e.g., CEA, CYFRA21-1), and quality of life (EORTC QLQ-C30/LC13).
Safety will be monitored via laboratory tests and adverse event reporting according to CTCAE v5.0.
The trial is expected to provide high-level evidence on whether the integration of Huaier granules into MWA-based therapy improves clinical outcomes and immune recovery in early inoperable NSCLC.
- Being tested
- Huaier Granule
- 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
Patients in this arm will undergo CT-guided percutaneous microwave ablation using a standard protocol (2450 MHz, 30-50 W, 5-10 minutes per lesion, multi-probe as needed based on tumor size). Seven days post-ablation, patients will start oral administration of Huaier granules at a dose of 10g, three times daily (TID), for 72 consecutive weeks. The combined therapy aims to improve local tumor control and modulate anti-tumor immunity.
| Study group | Role | What they receive |
|---|---|---|
| MWA + huaier | Experimental | MWA + huaier Receives: Drug: Huaier Granule |
| MWA | Experimental | MWA Receives: Drug: Huaier Granule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
PFS is defined as the time from randomization to disease progression or death from any cause, whichever occurs first. Disease progression will be assessed based on RECIST 1.1 criteria through imaging evaluations. Patients who are alive and progression-free at the time of analysis will be censored at their last disease assessment.
Measured: Up to 24 months after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 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 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xin Ye
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xin Ye, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07197853
- Sponsor's protocol ID
- HAMSTER
- Acronym
- HAMSTER
- Status last verified
- Sep 2025
- First submitted
- 26 Sep 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Center, Randomized Controlled Trial to Evaluate the Clinical Efficacy and Safety of Microwave Ablation Combined With Huaier Granules in Patients With Stage IA Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07197853
- Acronym / sponsor ID
- HAMSTER / HAMSTER
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Xin YeUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 29 Sep 2025 (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 prospective, single-center, randomized controlled clinical trial aims to evaluate the efficacy and safety of microwave ablation (MWA) combined with Huaier granules in patients with inoperable stage IA non-small cell lung cancer (NSCLC). A total of 180 eligible patients will be randomly assigned to receive either MWA alone or MWA combined with Huaier granules. The primary endpoint is progression-free survival (PFS) assessed by RECIST 1.1 criteria. Secondary outcomes include local progression rate (LPR), overall survival (OS), tumor markers, immune function, and quality of life. Safety will be evaluated using the CTCAE v5.0 criteria. The study seeks to determine whether the combined therapy offers improved tumor control and immune benefits over MWA alone.
Detailed description
Lung cancer remains the leading cause of cancer-related death globally, with non-small cell lung cancer (NSCLC) accounting for approximately 85% of cases. A significant proportion of early-stage NSCLC patients are deemed inoperable due to comorbidities or patient refusal. Microwave ablation (MWA) is an established local therapy for inoperable NSCLC, yet incomplete ablation and immune suppression in the tumor microenvironment remain challenges, especially in tumors >3 cm or near critical structures.
This study investigates whether the addition of Huaier granules, a polysaccharide-based traditional Chinese medicine shown to modulate immune function and improve outcomes post-ablation in liver cancer, can enhance the efficacy of MWA in early-stage NSCLC. Huaier may promote dendritic cell maturation, Th1 immune responses, and restore immune balance after incomplete MWA (iMWA).
Eligible patients (stage IA-IIA NSCLC without lymph node metastasis, ECOG ≤2, life expectancy >3 months) will be randomized 1:1 into two groups. The experimental group will receive CT-guided MWA followed by oral Huaier granules (10 g three times daily for 72 weeks), while the control group receives MWA alone. Follow-up will occur at months 1, 3, 6, 12, and 24.
Primary endpoint: progression-free survival (PFS). Secondary endpoints: local progression rate (LPR), overall survival (OS), immune cell profiles, tumor markers (e.g., CEA, CYFRA21-1), and quality of life (EORTC QLQ-C30/LC13).
Safety will be monitored via laboratory tests and adverse event reporting according to CTCAE v5.0.
The trial is expected to provide high-level evidence on whether the integration of Huaier granules into MWA-based therapy improves clinical outcomes and immune recovery in early inoperable NSCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MWA + huaier | Experimental | Drug: Huaier GranuleMWA + huaier |
| MWA | Experimental | Drug: Huaier GranuleMWA |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- ≥ 18 years old.
- Histologically or cytologically confirmed IA stage non-small cell lung cancer (NSCLC) that is inoperable.
- 0-2 (Eastern Cooperative Oncology Group performance status).
- Patients must have received no prior systemic treatment for lung cancer.
- Ability to provide written informed consent and willingness to comply with study requirements.
Key exclusion criteria (16 listed)
- Active or history of other malignancies within the past 5 years, except for non-melanoma skin cancer or in situ carcinoma.
- Cardiovascular disease (e.g., recent myocardial infarction, unstable angina, or severe arrhythmia)
- Uncontrolled diabetes or hypertension
- Active infections requiring systemic antibiotics or antivirals
- Women who are pregnant, breastfeeding, or planning to become pregnant during the study.
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 GranulePatients in this arm will undergo CT-guided percutaneous microwave ablation using a standard protocol (2450 MHz, 30-50 W, 5-10 minutes per lesion, multi-probe as needed based on tumor size). Seven days post-ablation, patients will start oral administration of Huaier granules at a dose of 10g, three times daily (TID), for 72 consecutive weeks. The combined therapy aims to improve local tumor control and modulate anti-tumor immunity. | Drug | MWA, MWA + huaier |
Primary outcome
Progression-Free Survival (PFS)
Time frame: Up to 24 months after treatment initiation
PFS is defined as the time from randomization to disease progression or death from any cause, whichever occurs first. Disease progression will be assessed based on RECIST 1.1 criteria through imaging evaluations. Patients who are alive and progression-free at the time of analysis will be censored at their last disease assessment.
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 29 Sep 2025.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Huaier Granule in people with Non-small Cell Lung Cancer (NSCLC) and Huaier Granules, run by Xin Ye.
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 16 inclusion and 16 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: opening soon, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Nan Wang, Doctor (86-15864028114, drwangnan@126.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: Up to 24 months after treatment initiation). 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 29 Sep 2025.