NCT06109454 Observation on the Therapeutic Effect of Huaier Granules in the Adjuvant Treatment of Non-small Cell Lung Cancer After Radical Surgery
| NCT ID | NCT06109454 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Liaoning Cancer Hospital & Institute |
| Condition | Non-small Cell Lung Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 240 participants |
| Start Date | 2024-03-21 |
| Primary Completion | 2025-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 240 participants in total. It began in 2024-03-21 with a primary completion date of 2025-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is a multicenter, prospective, and observational clinical study aimed at exploring whether the 3-year DFS in the Huaier group is not inferior to the control group receiving standard platinum dual-drug chemotherapy.
Eligibility 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.
Contact & Investigator
Hongxu Liu, PhD
PRINCIPAL INVESTIGATOR
Liaoning Cancer Hospital & Institute
Frequently Asked Questions
Who can join the NCT06109454 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Non-small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06109454 currently recruiting?
Yes, NCT06109454 is actively recruiting participants. Contact the research team at hxliu@cmu.edu.cn for enrollment information.
Where is the NCT06109454 trial being conducted?
This trial is being conducted at Shenyang, China.
Who is sponsoring the NCT06109454 clinical trial?
NCT06109454 is sponsored by Liaoning Cancer Hospital & Institute. The principal investigator is Hongxu Liu, PhD at Liaoning Cancer Hospital & Institute. The trial plans to enroll 240 participants.
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