An observational study in Non-small Cell Lung Cancer, sponsored by Liaoning Cancer Hospital & Institute. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-05-10.
Sponsored by Liaoning Cancer Hospital & Institute · Observational
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.
This study is a small sample observational study, mainly exploring whether the 3-year DFS of the Huaier group is not inferior to the control group receiving standard platinum dual drug chemotherapy. Therefore, this study will conduct a small sample exploratory analysis. It is expected to include 240 non-small cell lung cancer patients who have been diagnosed with stage Ⅱ-ⅢA and are eligible for surgery at selected research centers from April 2023 to July 2025. Among them, 120 patients in the Huaier Granule group refused to undergo adjuvant chemotherapy due to reasons such as intolerance or disagreement, and agreed to receive Huaier Granule monotherapy as an adjuvant treatment; There are 120 patients in the control group, all of whom plan to receive standard chemotherapy as an adjuvant treatment plan (including platinum based dual-drug combination chemotherapy).
6,641 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,665 are open to participants now.
This study's planned enrollment of 240 is above the median of 164 across 974 observational studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Liaoning Cancer Hospital & Institute is the lead sponsor of 23 studies on the registry; 12 are open to participants now.
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The study population is resectable stage Ⅱ-ⅢA non-small cell lung cancer patients.
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Exclusion Criteria:
The subjects voluntarily gave up postoperative adjuvant therapy, including chemotherapy, targeted therapy, immunotherapy, and radiation therapy, and agreed to take Huaier granules.
Drug: Huaier granule
The subjects received standard platinum dual-drug chemotherapy.
Other: Control
The 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.
Also known as: Z20000109（NMPA Approval Number）
The 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.
Time frame: start of treatment until 3-year follow-up
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
Time frame: start of treatment until 1-year or 2-year follow-up
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.
Time frame: start of treatment until 1-year, 2-year or 3-year follow-up
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.
Time frame: start of treatment until 1-year, 2-year or 3-year follow-up
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
Time frame: start of treatment until 1-year, 2-year or 3-year follow-up
Quality of Life Score (SF-36 Scale)
The Health Survey Short Form\[(SF-36 Scale (Chinese Version) \]developed by the US Medical Bureau research team was used for evaluation. The scale has 36 items and aims to evaluate the health and functional status of multiple age groups, different diseases, and control populations.Note that all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.
Time frame: start of treatment until 3-year follow-up
The incidence and severity of adverse events (AE) and severe adverse events (SAE)
The definitions and severity grading of AE and SAE can refer to the corresponding descriptions in the definition and evaluation section of AE. The incidence rate is defined as the proportion of subjects who have experienced AE and SAE to the corresponding total population.
Time frame: start of treatment until 3-year follow-up
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.
Time frame: start of treatment until 3-year follow-up
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Carcinoma, Non-Small-Cell Lung →
Liaoning Cancer Hospital & Institute