Status:
NOT_YET_RECRUITING
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
Lead Sponsor:
Xin Ye
Conditions:
Non-small Cell Lung Cancer (NSCLC)
Huaier Granules
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief 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 sta...
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...
Eligibility Criteria
Inclusion
- 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 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.
- \-
Exclusion
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT07197853
Start Date
October 1 2025
End Date
June 30 2028
Last Update
September 29 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.