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

NCT07358520 | Not Yet Recruiting Phase 4

• 1 other identifier: HE-202508
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Proteinuria

Keywords

Huaier Granules; Proteinuria; Bevacizumab; Anlotinib

Outcome Measures

Primary Outcomes (1)

• 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.

  Start of treatment until 16-week follow-up

Secondary Outcomes (3)

• 48-week Recurrence Rate for Proteinuria Treatment

  Start of treatment until 48-week follow-up

• 48-week Resumption and Discontinuation Rates for Bevacizumab or Anlotinib after Proteinuria Treatment

  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

  Start of treatment until 48-week follow-up

Study Arms (2)

Huaier Granules

EXPERIMENTAL

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

Anlotinib and Bevacizumab

ACTIVE COMPARATOR

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

Interventions

Huaier Granule DRUG

Take orally, 10g each time, three times daily.

Huaier Granules

Anlotinib and Bevacizumab DRUG

Administer according to clinical routine practice. Refer to the respective drug prescribing information for specific usage.

Anlotinib and Bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (2)

Xuzhou Central Hospital

Xuzhou, Jiangsu, China

Location

Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Proteinuria

Interventions

anlotinib; Bevacizumab

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Jialei Wang, phD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jialei Wang, phD

CONTACT

0086-18017312369; luwangjialei@126.com

Xinmin Zhao, phD

CONTACT

0086-18017312493

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: January 22, 2026
• Study Start: January 28, 2026
• Primary Completion (Estimated): January 28, 2027
• Study Completion (Estimated): January 28, 2028
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)