NCT07358520

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

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Proteinuria

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-01-28
• Primary completion: 2027-01-28
• Completion: 2028-01-28
• First posted: 2026-01-22
• Last updated: 2026-01-22

Locations

2 sites across 1 country: China