Clinical trial NCT06109454: Observation on the Therapeutic Effect of Huaier Granules in the Adjuvant Treatment of Non-small Cell Lung Cancer After Radical Surgery
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-small Cell Lung Cancer
Keywords: Huaier granule
Non-small Cell Lung Cancer
Efficacy
Safety
Lead sponsor: Liaoning Cancer Hospital & Institute
Sponsor class: OTHER
Collaborators: name: LinkDoc Technology (Beijing) Co. Ltd.
name: Huazhong University of Science and Technology
First posted: 2023-10-31
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is resectable stage Ⅱ-ⅢA non-small cell lung cancer patients.

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.

Detailed description: 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).

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.

Primary outcomes:
measure: 3-year disease-free survival (DFS) rate
timeFrame: start of treatment until 3-year follow-up
Secondary outcomes:
measure: 1-year or 2-year DFS rate
timeFrame: start of treatment until 1-year or 2-year follow-up
measure: 1-year, 2-year or 3-year overall survival (OS) rate
timeFrame: start of treatment until 1-year, 2-year or 3-year follow-up
measure: 1-year, 2-year or 3-year local recurrence free survival (LRFS) rates
timeFrame: start of treatment until 1-year, 2-year or 3-year follow-up
measure: 1-year, 2-year or 3-year distant metastasis free survival (DMFS) rates
timeFrame: start of treatment until 1-year, 2-year or 3-year follow-up
measure: Quality of Life Score (SF-36 Scale)
timeFrame: start of treatment until 3-year follow-up
measure: The incidence and severity of adverse events (AE) and severe adverse events (SAE)
timeFrame: start of treatment until 3-year follow-up
Other outcomes:
measure: Changes in peripheral blood lymphocyte subpopulations
timeFrame: start of treatment until 3-year follow-up
Locations:
city: Shenyang
country: China
facility: Liaoning Cancer Hospital & Institute
state: Liaoning
Study officials:
affiliation: Liaoning Cancer Hospital & Institute
name: Hongxu Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References: