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Trial Title:
Observation on the Therapeutic Effect of Huaier Granules in the Adjuvant Treatment of Non-small Cell Lung Cancer After Radical Surgery
NCT ID:
NCT06109454
Condition:
Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
Huaier granule
Non-small Cell Lung Cancer
Efficacy
Safety
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Huaier granule
Description:
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.
Arm group label:
Huaier Granule
Other name:
Z20000109（NMPA Approval Number）
Intervention type:
Other
Intervention name:
Control
Description:
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.
Arm group label:
Control
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).
Criteria for eligibility:
Study pop:
The study population is resectable stage Ⅱ-ⅢA non-small cell lung cancer patients.
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Liaoning Cancer Hospital & Institute
Address:
City:
Shenyang
Zip:
110801
Country:
China
Status:
Recruiting
Contact:
Last name:
Hongxu Liu, PhD
Phone:
+8618040097698
Email:
hxliu@cmu.edu.cn
Start date:
March 21, 2024
Completion date:
October 2028
Lead sponsor:
Agency:
Liaoning Tumor Hospital & Institute
Agency class:
Other
Collaborator:
Agency:
LinkDoc Technology (Beijing) Co. Ltd.
Agency class:
Industry
Collaborator:
Agency:
Huazhong University of Science and Technology
Agency class:
Other
Source:
Liaoning Tumor Hospital & Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06109454
