Observation on the Therapeutic Effect of Huaier Granules in the Adjuvant Treatment of Non-small Cell Lung Cancer After Radical Surgery

Официальное название

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

Обзор

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.

Подробное описание

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).

Вмешательства

• Препарат Huaier granule
  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 specif
• Другое Control
  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.

Первичные конечные точки

• 3-year disease-free survival (DFS) rate [Срок оценки: start of treatment until 3-year follow-up]

Вторичные конечные точки (6)

• 1-year or 2-year DFS rate [Срок оценки: start of treatment until 1-year or 2-year follow-up]
• 1-year, 2-year or 3-year overall survival (OS) rate [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: start of treatment until 1-year, 2-year or 3-year follow-up]
• Quality of Life Score (SF-36 Scale) [Срок оценки: start of treatment until 3-year follow-up]
• The incidence and severity of adverse events (AE) and severe adverse events (SAE) [Срок оценки: start of treatment until 3-year follow-up]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Китай · 1 центр

• Liaoning Cancer Hospital & Institute — Шэньян

Идентификаторы

NCT: NCT06109454 · HE-202306

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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