Clinical Study on the Use of Huaier Granules for the Treatment of Proteinuria Related to Bevacizumab and Anlotinib in Lung Cancer Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Huaier Granule, Anlotinib and Bevacizumab.
- Who it may be relevant to
- Registry conditions: Proteinuria. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective, Multicenter, Parallel-Controlled Clinical Study on the Use of Huaier Granules for the Treatment of Bevacizumab- and Anlotinib-Related Proteinuria in Lung Cancer Patients
Overview
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.
Detailed description
This study is a prospective, multicenter, parallel-controlled exploratory trial. It plans to enroll 40 subjects diagnosed with malignant lung tumors, who will visit the selected research centers from October 2025 to October 2026. All subjects will be assigned to either the control group or the experimental group based on clinical management and their own preference. Subjects in the control group will receive no therapeutic intervention, while those in the experimental group will be administered Huaier Granules.Throughout the study period, the planned duration for subject recruitment and enrollment is 12 months. The total follow-up duration for enrolled subjects is 48 weeks. After enrollment, subjects will be followed up every 2 weeks during the first 8 weeks, and then every 4 weeks thereafter. Follow-ups will continue until the study ends, the subject withdraws from the study for any reason, is lost to follow-up, or dies, whichever occurs first.
Interventions
- Drug Huaier Granule
Take orally, 10g each time, three times daily. - Drug Anlotinib and Bevacizumab
Administer according to clinical routine practice. Refer to the respective drug prescribing information for specific usage.
Primary outcome measures
- 16-week Efficacy Rate for Proteinuria Treatment [Time frame: Start of treatment until 16-week follow-up]
Secondary outcome measures (3)
- 48-week Recurrence Rate for Proteinuria Treatment [Time frame: Start of treatment until 48-week follow-up]
- 48-week Resumption and Discontinuation Rates for Bevacizumab or Anlotinib after Proteinuria Treatment [Time frame: Start of treatment until 48-week follow-up]
- Incidence and Severity of Other Adverse Reactions (including but not limited to hypertension, bleeding, and gastrointestinal perforation) after 48 weeks of Proteinuria Treatment [Time frame: Start of treatment until 48-week follow-up]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Xuzhou Central Hospital — Xuzhou
- Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai
Identifiers
NCT: NCT07358520 · HE-202508