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

January 14, 2026 updated by: Jialei Wang, Fudan University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Xinmin Zhao, phD
  • Phone Number: 0086-18017312493

Study Locations

  • China
    • Jiangsu
      • Xuzhou, Jiangsu, China
        • Xuzhou Central Hospital
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Huaier Granules
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.
Drug: Huaier Granule
Take orally, 10g each time, three times daily.
Active Comparator: Anlotinib and Bevacizumab
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.
Drug: Anlotinib and Bevacizumab
Administer according to clinical routine practice. Refer to the respective drug prescribing information for specific usage.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
16-week Efficacy Rate for Proteinuria Treatment
Time Frame: 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.
Start of treatment until 16-week follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
48-week Recurrence Rate for Proteinuria Treatment
Time Frame: Start of treatment until 48-week follow-up
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.
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
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.
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
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
Start of treatment until 48-week follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Principal Investigator: Jialei Wang, phD, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 28, 2026

Primary Completion (Estimated)

January 28, 2027

Study Completion (Estimated)

January 28, 2028

Study Registration Dates

First Submitted

January 14, 2026

First Submitted That Met QC Criteria

January 14, 2026

First Posted (Actual)

January 22, 2026

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HE-202508

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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