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.
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.
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 study population is resectable stage Ⅱ-ⅢA non-small cell lung cancer patients.
Case-control
Prospective
Huaier granule
DrugThe subjects voluntarily gave up postoperative adjuvant therapy, including chemotherapy, targeted therapy, immunotherapy, and radiation therapy, and agreed to take Huaier granules.The subjects took Huaier granules orally, one bag (10g) per time, three times a day. Until the end of the study, intolerable toxicity, withdrawal from the study for any reason or death, or when the researcher determines that there is no further benefit, whichever occurs first. Please refer to the drug manual for specific usage. It is recommended that patients start taking Huaier granules 1-2 weeks after surgery.
Control
Other interventionThe subjects received standard platinum dual drug chemotherapy.The subjects were treated with carboplatin injection (300mg/m2, intravenous injection, first day) combined with pemetrexed disodium (pathological type: adenocarcinoma, intravenous injection, 500mg/m2) or albumin bound paclitaxel (pathological type: squamous cell carcinoma, 260mg/m2, intravenous injection, first day) every three weeks, with a maximum of four cycles.
3-year disease-free survival (DFS) rate
The proportion of participants who did not experience disease recurrence or death within 3 years after undergoing lung cancer radical surgery.
1-year or 2-year DFS rate
The proportion of participants who did not experience disease recurrence or death within 1 or 2 years after undergoing lung cancer radical surgery
1-year, 2-year or 3-year overall survival (OS) rate
The proportion of subjects who survived within 1 year, 2 years or 3 years after undergoing radical lung cancer surgery among all subjects.
1-year, 2-year or 3-year local recurrence free survival (LRFS) rates
The proportion of subjects who did not experience local recurrence of lung cancer within 1 year, 2 years or 3 years after undergoing radical lung cancer surgery.
1-year, 2-year or 3-year distant metastasis free survival (DMFS) rates
The proportion of subjects who did not experience distant metastasis within 1 year, 2 years, or 3 years after undergoing lung cancer radical surgery
Changes in peripheral blood lymphocyte subpopulations
Observe and describe the changes in peripheral blood lymphocyte subpopulations from baseline, peripheral blood lymphocyte subpopulations include but are not limited to CD3+T, CD4+T, and CD8+T.
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Liaoning Cancer Hospital & Institute
Lead sponsor
LinkDoc Technology (Beijing) Co. Ltd.
Collaborator
Huazhong University of Science and Technology
Collaborator
