Clinical Efficacy and Safety of Microwave Ablation Combined With Huaier Granules in Patients With… (NCT07197853) | Clinical Trial Compass
Not Yet RecruitingPhase 3
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
180 participantsStarted 2025-10-01
Plain-language 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). 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
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).
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
Exclusion Criteria
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
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 treat…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression-Free Survival (PFS)
Timeframe: Up to 24 months after treatment initiation