Huaier Granule: Take orally, 10g each time, three times daily.
Anlotinib and Bevacizumab: Administer according to clinical routine practice. Refer to the respective drug prescribing information for specific usage.
Study summary
This study is a prospective, multicenter, parallel-controlled clinical trial designed to evaluate the therapeutic efficacy of Huaier Granules for proteinuria occurring in lung cancer patients undergoing treatment with either Bevacizumab or Anlotinib.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Age ≥18 years;
* Histopathologically confirmed diagnosis of lung cancer;
* Receiving Bevacizumab or Anlotinib treatment;
* Positive urine protein detection, with 0.15g \< 24-hour urinary protein quantification \< 3.5g;
* No treatment with Huaier Granules within one month prior to enrollment;
* Expected survival time not less than 6 months;
* Voluntary participation in this study and provision of signed informed consent.
Exclusion Criteria:
* Known allergy, contraindication, or caution to any component of Huaier Granules;
* Inability to take oral medication;
* Required or ongoing use of drugs known to potentially affect proteinuria, including but not limited to ACE inhibitors, glucocorticoids (\>3 weeks), and Chinese patent medicines (as per respective drug prescribing information);
* Proteinuria caused by underlying diseases, including but not limited to nephropathy, hypertension, urinary tract infection, systemic lupus erythematosus, multiple myeloma, etc.;
* Women who are pregnant, breastfeeding, or planning pregnancy;
* Currently participating in other clinical trials investigating drugs for treating proteinuria;
* Refusal to cooperate with follow-up;
* Any other reasons deemed by the investigator as unsuitable for participation in this study.
Primary outcome measure(s)
16-week Efficacy Rate for Proteinuria Treatment — Start of treatment until 16-week follow-up It defined as the proportion of subjects achieving complete remission, partial remission, or stable disease according to proteinuria treatment efficacy evaluation at 16 weeks, relative to the total number of subjects in both groups.
Trial sites (2)
Facility
City
Region
Status
Xuzhou Central Hospital
Xuzhou
Jiangsu
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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