Observation on the Therapeutic Effect of Huaier Granules in the Adjuvant Treatment of Non-small Cell Lung Cancer After Radical Surgery
Recruiting · NCT06109454 · Observational (researchers observe without assigning treatment) · Lead sponsor: Liaoning Cancer Hospital & Institute
View the official record on ClinicalTrials.gov →Interventions studied
ControlHuaier granule
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
1 location listed.
- Liaoning Cancer Hospital & Institute - Shenyang, Liaoning, China