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.
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;
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.;
Parallel
Huaier Granule
DrugTake orally, 10g each time, three times daily.
Anlotinib and Bevacizumab
DrugAdminister according to clinical routine practice. Refer to the respective drug prescribing information for specific usage.
16-week Efficacy Rate for Proteinuria Treatment
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.
48-week Recurrence Rate for Proteinuria Treatment
It defined as the proportion of subjects whose proteinuria reverts to positive (≥1+) after becoming negative during treatment, relative to the total number of subjects.
48-week Resumption and Discontinuation Rates for Bevacizumab or Anlotinib after Proteinuria Treatment
It defined as the proportion of subjects who, due to worsening proteinuria, required temporary suspension of bevacizumab or anlotinib and subsequently resumed treatment after proteinuria alleviation, relative to the total number of subjects.
Incidence and Severity of Other Adverse Reactions (including but not limited to hypertension, bleeding, and gastrointestinal perforation) after 48 weeks of Proteinuria Treatment
Incidence is defined as the proportion of subjects experiencing other adverse reactions (including but not limited to hypertension, bleeding, and gastrointestinal perforation) relative to the corresponding total population. Severity will be assessed as per the relevant descriptions in the adverse event definitions and evaluation section
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