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

NCT06109454 | Recruiting DMC

• 1 other identifier: HE-202306
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Cancer

Keywords

Huaier granule; Non-small Cell Lung Cancer; Efficacy; Safety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 1-year or 2-year DFS rate

  start of treatment until 1-year or 2-year follow-up

• 1-year, 2-year or 3-year overall survival (OS) rate

  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

  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

  start of treatment until 1-year, 2-year or 3-year follow-up

• Quality of Life Score (SF-36 Scale)

  start of treatment until 3-year follow-up

Other Outcomes (1)

• Changes in peripheral blood lymphocyte subpopulations

  start of treatment until 3-year follow-up

Study Arms (2)

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

Control

The subjects received standard platinum dual-drug chemotherapy.

Other: Control

Interventions

Huaier granule DRUG

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）

Huaier Granule

Control OTHER

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.

Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Liaoning Cancer Hospital & Institute: lead
• LinkDoc Technology (Beijing) Co. Ltd.: collaborator
• Huazhong University of Science and Technology: collaborator

Study Sites (1)

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, 110801, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Hongxu Liu, PhD

  Liaoning Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongxu Liu, PhD

CONTACT

+8618040097698; hxliu@cmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: October 31, 2023
• Study Start: March 21, 2024
• Primary Completion: September 1, 2025
• Study Completion (Estimated): October 1, 2028
• Last Updated: May 10, 2024

Record last verified: 2024-05

Locations

CN (1)