Clinical trial · Interventional
Effect of Huaier Granule on Nephrotoxicity Associated With Targeted Therapy for Advanced Hepatobiliary Malignancies.
Effect of Huaier Granule on Nephrotoxicity Associated With Anti-angiogenesis Targeted Therapy for Advanced Hepatobiliary Malignancies: a Single-arm, Single-center, Exploratory Study.
NCT05673824CI-TRIAL-00102764completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nephrotoxicity | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Huaier Granule | Drug | — | UNRESOLVED |
| VEGFR-TKIs | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Huaier Granule Group
- description
- Huaier Granule+VEGFR-TKIs
- interventionNames
- Drug: Huaier Granule
- Drug: VEGFR-TKIs
Primary outcomes (1)
- measure
- The effective rate on proteinuria treatment after 8 weeks of Huaier granule
- timeFrame
- 8 weeks
- description
- Proportion of subjects who achieved complete remission (CR) or partial remission (PR) or stable disease (SD) after 8 weeks treatment of Huaier granule. Perform a 24-hour urine collection for protein measurement, CR is defined as urine protein level≤0.3g/24h; PR is defined as urine protein level\>0.3g/24h and\<3.5g/24h, and decrease more than 30% from baseline; SD is defined as urine protein level \>0.3g/24h and\<3.5g/24h, and decrease less than or equal to 30% from baseline (or increase less than or equal to 20% from baseline); treatment failure is defined as at least two 24-hour urine protein tests show an increase of urine protein level of more than 20% from baseline or≥3.5 g/24h, or admission to renal replacement therapy or death.
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.