Huaier Granule's effect on kidney damage from targeted therapy in liver cancer patients
Effect of Huaier Granule on Nephrotoxicity Associated With Anti-angiogenesis Targeted Therapy for Advanced Hepatobiliary Malignancies: a Single-arm, Single-center, Exploratory Study.
This study is testing if Huaier Granule can help reduce kidney damage in liver cancer patients who are taking certain targeted therapies.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 53 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | bevacizumab, lenvatinib, chemotherapy, immunotherapy |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT05673824 on ClinicalTrials.gov |
What this trial studies
This exploratory study investigates the impact of Huaier Granule on nephrotoxicity caused by anti-angiogenesis targeted therapy in patients with advanced hepatobiliary malignancies. It is a single-arm, single-center, prospective study conducted at Fudan University Shanghai Cancer Center. The study aims to assess the incidence of proteinuria, a common side effect of targeted therapies, and evaluate whether Huaier Granule can mitigate this adverse reaction. Eligible participants are those diagnosed with advanced liver cancer and currently receiving VEGFR-TKIs, with specific urine protein levels.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with advanced hepatobiliary malignancies who are experiencing proteinuria while on VEGFR-TKIs.
Not a fit: Patients who are allergic to Huaier granule or those unable to take medications orally may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel therapeutic option to reduce kidney damage in patients undergoing treatment for advanced liver cancer.
How similar studies have performed: While the use of Huaier Granule is relatively novel in this context, other studies have shown promising results in using herbal extracts to mitigate side effects of cancer therapies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 18 years and older 2. Meeting the clinical diagnostic criteria of primary hepatobiliary malignancies, diagnosed as advanced hepatobiliary malignancies. 3. Receiving VEGFR-TKIs for advanced hepatobiliary malignancies. 4. Urinalysis indicates urine protein positive. 5. Urine protein level greater than 0.3 grams and less than 3.5 grams per 24 hours. 6. No Huaier granule were used within 1 month before enrollment. 7. Agree to use Huaier granule after enrollment. 8. Expected survival time not less than 6 months. 9. Volunteer to join the study and sign the informed consent form. Exclusion Criteria: 1. Allergic to the components of Huaier granule, or avoid to use Huaier granule or use with caution. 2. Not able to take medication orally. 3. Must use or are using drugs that may affect proteinuria other than VEGFR-TKIs, including but not limited to bevacizumab, ACEI, glucocorticoids (more than 3 weeks), traditional Chinese medicine (refer to drug instructions). 4. Concomitant with other diseases that can lead to proteinuria, including but not limited to nephropathy, hypertension, urinary infections, systemic lupus erythematosus, multiple myeloma. 5. Pregnant or lactating women or women prepare for pregnancy. 6. Participating in clinical trials of other drugs that intend to treat proteinuria. 7. Refused to cooperate with follow-up. 8. Other reasons that the researcher considers unsuitable to participate in this study.
Where this trial is running
Shanghai, Shanghai
- Fudan University Shanghai Cancer Center — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Lu Wang — Fudan University
- Study coordinator: Lu Wang
- Email: cms024mm@163.com
- Phone: +86 18121299555
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.