Clinical Study on the Use of Huaier Granules for the Treatment of Proteinuria Related to Bevacizumab and Anlotinib in Lung Cancer Patients

Fudan University

Status and phase: Not yet enrolling; Phase 4

Conditions: Proteinuria

Treatments: Drug: Anlotinib and Bevacizumab; Drug: Huaier Granule

Study type: Interventional

Funder types: Other

Identifiers

NCT07358520

HE-202508

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Huaier Granules

Experimental group

Description:

Take orally, 10g each time, three times a day. Participants in the experimental group should continue treatment for at least 24 weeks or until treatment failure, intolerable toxicity, withdrawal from the study for any reason, or death, whichever occurs first; or until the investigator determines that there is no further benefit. For specific usage, refer to the drug instructions.

Treatment:

Drug: Huaier Granule

Anlotinib and Bevacizumab

Active Comparator group

Description:

Administer according to clinical routine practice. Refer to the respective drug prescribing information for specific usage. Continue treatment until disease progression, intolerable toxicity, withdrawal from the study for any reason, or death, whichever occurs first.

Treatment:

Drug: Anlotinib and Bevacizumab