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

NCT07197853 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: HAMSTER
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Non-small Cell Lung Cancer (NSCLC); Huaier Granules; Microwave Ablation

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 24 months after treatment initiation

Study Arms (2)

MWA + huaier

EXPERIMENTAL

MWA + huaier

Drug: Huaier Granule

MWA

EXPERIMENTAL

MWA

Drug: Huaier Granule

Interventions

Huaier Granule DRUG

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.

MWA; MWA + huaier

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age:
• ≥ 18 years old.
• Diagnosis:
• Histologically or cytologically confirmed IA stage non-small cell lung cancer (NSCLC) that is inoperable.
• ECOG Performance Status:
• (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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xin Ye: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Nan Wang, Doctor

CONTACT

86-15864028114; drwangnan@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: September 29, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL