Effect of Huaier Granule on Nephrotoxicity Associated With Targeted Therapy for Advanced Hepatobi… (NCT05673824) | Clinical Trial Compass
CompletedPhase 2
Effect of Huaier Granule on Nephrotoxicity Associated With Targeted Therapy for Advanced Hepatobiliary Malignancies.
China76 participantsStarted 2023-01-03
Plain-language summary
This is a prospective, single-arm, single-center, exploratory study. The purpose of this study is to explore the effect of Huaier Granule on nephrotoxicity associated with anti-angiogenesis targeted therapy for advanced hepatobiliary malignancies.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 18 years and older
✓. Meeting the clinical diagnostic criteria of primary hepatobiliary malignancies, diagnosed as advanced hepatobiliary malignancies.
✓. Receiving VEGFR-TKIs for advanced hepatobiliary malignancies.
✓. Urinalysis indicates urine protein positive.
✓. Urine protein level greater than 0.3 grams and less than 3.5 grams per 24 hours.
✓. No Huaier granule were used within 1 month before enrollment.
✓. Agree to use Huaier granule after enrollment.
✓. Expected survival time not less than 6 months.
Exclusion criteria
✕. Allergic to the components of Huaier granule, or avoid to use Huaier granule or use with caution.
✕. Not able to take medication orally.
✕. 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).
✕. Concomitant with other diseases that can lead to proteinuria, including but not limited to nephropathy, hypertension, urinary infections, systemic lupus erythematosus, multiple myeloma.
What they're measuring
1
The effective rate on proteinuria treatment after 8 weeks of Huaier granule