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Multicenter, Randomized, Parallel-Controlled Clinical Study of Huaier Granules in the Treatment of Proteinuria Associated with Immunotherapy and Anti-Angiogenic Therapy in Breast Cancer Patients

Multicenter, Randomized, Parallel-Controlled Clinical Study of Huaier Granules in the Treatment of Proteinuria Associated with Immunotherapy and Anti-Angiogenic Therapy in Breast Cancer Patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109379
Enrollment
Unknown
Registered
2025-09-17
Start date
2025-10-01
Completion date
Unknown
Last updated
2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Interventions

Group A: Anti-tumor treatment + Proteinuria treatment + Huaier Granules treatment
:Combination of Huaier Granules on the basis of conventional anti-tumor treatment and proteinuria treatment
Group B: Anti-tumor treatment + Proteinuria treatment:Conventional anti-tumor treatment and proteinuria treatment

Sponsors

Fudan University Shanghai Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Women aged 18-75 years; 2. Clinically diagnosed with breast cancer as judged by the investigator; 3. Current or previous immunotherapy, or anti-vascular therapy; 4. Proteinuria in routine urine examination is +/++/+++ for the first time; 5.0.15g<24h urine protein quantification<3.5g; 6. ECOG score: 0~1 points; 7. KPS score =70; 8. No treatment with locust ear granules within 1 month before enrollment; 9. Expected survival time not less than 6 months; 10. Volunteer to join this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Known history of chronic kidney disease (eGFR<60 ml/min/1.73m²) or diabetic nephropathy; 2. Proteinuria caused by diseases, including but not limited to kidney disease, hypertension, urinary system infection, systemic lupus erythematosus, multiple myeloma, etc.; 3. Current use of ACEI/ARB drugs (stable dose = 4 weeks before enrollment is allowed); 4. Known allergy to the components of locust ear granules or avoid using and use locust ear granules with caution; 5. Pregnant or lactating women or planning to become pregnant; 6. Participating in other clinical trials of proteinuria drugs; 7. Other reasons that make the investigator unsuitable for participating in this study.

Design outcomes

Primary

MeasureTime frame
Effective rate of proteinuria treatment after 8 weeks of Huaier Granules therapy;;

Countries

China

Contacts

Public ContactZhi-Ming Shao

Fudan University Shanghai Cancer Center

zhimingshao@yahoo.com+86 21 64175590

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026