Evaluating Huaier Granules for Non-small Cell Lung Cancer After Surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.