NCT07197853Not 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
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
Source: ClinicalTrials.gov · Last updated 29 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- First submitted
- 26 Sept 2025
- Start date
- 1 Oct 2025
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- Xin Ye
- Diseases
- Lung cancer
- NCT number
- NCT07197853
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 180
- From 1 Oct 2025 to the primary completion date, 30 Jun 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Severe Concurrent Diseases:
- Immunosuppressive Therapy:
- Patients who have received immunosuppressive therapy within 30 days prior to enrollment.
Other illness
- Other Malignancies:
- Active or history of other malignancies within the past 5 years, except for non-melanoma skin cancer or in situ carcinoma.
- 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
- 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.
Other
- Pregnancy or Breastfeeding:
- Women who are pregnant, breastfeeding, or planning to become pregnant during the study.
- Other Contraindications:
- \-
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.