Evaluating Huaier Granules for Non-small Cell Lung Cancer After Surgery
Observational Study on the Efficacy and Safety of Huaier Granules Compared With Platinum Containing Dual Drug Combination Chemotherapy in Adjuvant Therapy for Resectable Stage II-IIIA Non-small Cell Lung Cancer After Radical Surgery
Liaoning Cancer Hospital & Institute · NCT06109454
This study is testing if Huaier granules can help people with non-small cell lung cancer stay cancer-free after surgery, compared to those who get standard chemotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 240 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Liaoning Cancer Hospital & Institute (other) |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Shenyang, Liaoning) |
| Trial ID | NCT06109454 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effectiveness of Huaier granules as an adjuvant treatment for patients with non-small cell lung cancer (NSCLC) who have undergone radical surgery. It will compare the three-year disease-free survival (DFS) rates of patients receiving Huaier granules to those receiving standard platinum-based chemotherapy. The study will include 240 patients diagnosed with stage II-IIIA NSCLC, with half opting for Huaier granules due to intolerance or disagreement with chemotherapy. Data will be collected from multiple research centers over a two-year period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with stage II-IIIA non-small cell lung cancer who have recently undergone radical surgery.
Not a fit: Patients who are allergic to Huaier granules or those requiring targeted therapy or immunotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide an alternative treatment option for NSCLC patients who cannot tolerate standard chemotherapy.
How similar studies have performed: While there is limited data on Huaier granules specifically, similar observational studies have shown promise in exploring alternative treatments for cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years old ≤ age ≤ 75, regardless of gender. * Confirmed as non-small cell lung cancer by histopathology, with pathological staging of stage Ⅱ-ⅢA. * Received radical R0 resection of lung cancer within 2 months before enrollment, and did not receive any postoperative adjuvant therapy or preoperative neoadjuvant therapy. * ECOG（Eastern Cooperative Oncology Group）score:0-2. * The patient voluntarily participated in the study, agreed to cooperate with the researcher for data collection, and signed an informed consent form. Exclusion Criteria: * Known to be allergic to the components of Huaier granules or avoid or use Huaier granules with caution (Huaier group). * Those who have difficulty swallowing, complete or incomplete gastrointestinal obstruction, active gastrointestinal bleeding, perforation, and other causes of difficulty in taking oral medication. * Non-small cell lung cancer patients who plan to receive targeted therapy, immunotherapy, chemotherapy combined with immunotherapy, radiotherapy, synchronous radiotherapy and chemotherapy during the study period. * The patient has a history of other new malignant tumors within 5 years. * The expected survival time of the patient is less than half a year. * Surgical complications that have not recovered or are accompanied by severe infections after radical resection of lung cancer. * Pregnant or lactating women or planned pregnancy preparation. * The patient has received other traditional Chinese patent medicines and simple preparations with anti-tumor effect in the past one month (including but not limited to compound cantharidin capsule, cinobufagin capsule, Kangai injection, Brucea javanica injection, etc., the specific instructions shall prevail). * The patient suffers from severe mental illness or other reasons that the researcher deems unsuitable to participate in this study.
Where this trial is running
Shenyang, Liaoning
- Liaoning Cancer Hospital & Institute — Shenyang, Liaoning, China (RECRUITING)
Study contacts
- Principal investigator: Hongxu Liu, PhD — Liaoning Cancer Hospital & Institute
- Study coordinator: Hongxu Liu, PhD
- Email: hxliu@cmu.edu.cn
- Phone: +8618040097698
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Non-small Cell Lung Cancer, Huaier granule, Efficacy, Safety