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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Huaier granule; Other: Control

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).

• Study Type: Observational
• Enrollment (Estimated): 240

Contacts and Locations

• Study Contact: Name: Hongxu Liu, PhD; Phone Number: +8618040097698; Email: hxliu@cmu.edu.cn

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110801
      • Recruiting
      • Liaoning Cancer Hospital & Institute
      • Contact: Hongxu Liu, PhD; Phone Number: +8618040097698; Email: hxliu@cmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population is resectable stage Ⅱ-ⅢA non-small cell lung cancer patients.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Huaier Granule; 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 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.; Other Names: Z20000109（NMPA Approval Number）
Control; The subjects received standard platinum dual-drug chemotherapy.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	start of treatment until 3-year follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	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	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.	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.	start of treatment until 3-year follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	start of treatment until 3-year follow-up

Collaborators and Investigators

• Sponsor: Liaoning Tumor Hospital & Institute
• Collaborators: Huazhong University of Science and Technology; LinkDoc Technology (Beijing) Co. Ltd.
• Investigators: Principal Investigator: Hongxu Liu, PhD, Liaoning Tumor Hospital & Institute

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: October 24, 2023
• First Submitted That Met QC Criteria: October 27, 2023
• First Posted (Actual): October 31, 2023

Study Record Updates

• Last Update Posted (Actual): May 10, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Safety; Efficacy; Non-small Cell Lung Cancer; Huaier granule
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: HE-202306

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No