A Phase 2 interventional study of Huaier Granule and VEGFR-TKIs in Nephrotoxicity, sponsored by Fudan University. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-09.
Sponsored by Fudan University · Phase 2, Interventional, and Treatment
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.
China is a country with a high incidence of liver cancer, and the incidence of primary liver cancer ranks the fourth among malignant tumors in China. Hepatocellular carcinoma (HCC) is the main type of liver cancer, accounting for 75% to 85%. About 39.0%-53.6% of HCC patients were already advanced when first visit and had lost the opportunity to receive radical treatment. Currently, anti-angiogenesis targeted drugs are recommended for the first- or second-line treatment of advanced hepatocellular carcinoma. Biliary tract carcinoma are rare, accounting for about 3% of all digestive system malignancies. BTC are aggressive and were usually found in advanced stage, with a 5-year survival rate less than 5%. For advanced BTC, chemotherapy is the mainly systematic therapy recommended by current guidelines, targeted therapy and immunotherapy have shown efficacy in the exploration of the first-line and post-line of BTC. Anti-angiogenesis targeted drugs including lenvatinib are recommended for the first- or second-line treatment of advanced BTC.
Kidney injury is one of the common adverse reactions of anti-angiogenesis targeted drugs, among which proteinuria is one of the most common adverse reactions. Multiple key clinical studies have shown that the incidence of proteinuria associated with targeted therapy ranges from 10% to 51%, and the incidence of drug reduction or interruption due to proteinuria ranges from 0.9% to 17%.
Huaier is an extract from a medicinal fungus. The main effective component of Huai Qi Huang granule is Trametes Robiniophila Murr, which has been used in the treatment of chronic kidney disease for more than ten years. It was found that the effect of Huai Qi Huang granule alone or combined with RASI in the treatment of proteinuria was better than conventional treatment. The effective component of Huaier granule is also Trametes Robiniophila Murr, and its content is higher than that of Huai Qi Huang granule. Therefore, it is speculated that Huaier granule have a certain effect on anti-angiogenesis targeted therapy associated proteinuria in advanced hepatobiliary malignancies.
In this study, 1 research centers will participate. This study planned to enroll 53 participants. All the participants will be treated with Huaier granule. In this study, participants will be followed up for 24 weeks.
234 studies on the registry are indexed under Proteinuria; 43 are open to participants now.
This study's enrollment of 76 is above the median of 60 across 164 interventional studies indexed under Proteinuria.
Browse Proteinuria studies →Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.
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Exclusion Criteria:
Huaier Granule+VEGFR-TKIs
Drug: Huaier Granule · Drug: VEGFR-TKIs
Treatment period: oral administration, 10g each time, 3 times a day. Continuous medication until the end of the study, failure of treatment, intolerable toxicity, withdrawal from the study for any reason or death, whichever occurs first; or after researcher's judgement, patient would no longer benefit from the treatment. If the treatment of hepatobiliary malignancies needs to be changed due to disease progression, whether to continue the medication or not should be determined by the researcher.
Treatment period: Therapeutic agents were selected according to clinical routine, including but not limited to Sorafenib, Lenvatinib, Donafenib, Regorafenib, Apatinib and Cabozantinib. Continuous medication until disease progression, intolerable toxicity, withdrawal from the study for any reason or death, whichever occurs first. Refer to drug instructions for specific usage.
The effective rate on proteinuria treatment after 8 weeks of Huaier granule
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.
Time frame: 8 weeks
Mean value of 24-hour urinary protein level change from baseline to 8 weeks treatment of Huaier granule
Mean value of the difference between baseline 24h urine protein level and the 24h urine protein level after 8 weeks treatment of Huaier granule.
Time frame: 8 weeks
Mean value of 24-hour urinary protein level decrease rate from baseline to 8 weeks treatment of Huaier granule
Decrease rate: percentage of the difference between baseline 24h urine protein level and the 24h urine protein level after 8 weeks treatment of Huaier granule in baseline 24h urine protein level.
Time frame: 8 weeks
Incidence and severity of renal adverse events (AE) after 8 weeks treatment of Huaier granule
Time frame: 8 weeks
Incidence and severity of serious renal adverse events (SAE) after 8 weeks treatment of Huaier granule
Time frame: 8 weeks
Incidence and severity of renal adverse events (AE) after 16 weeks treatment of Huaier granule
Time frame: 16 weeks
Incidence and severity of serious renal adverse events (SAE) after 16 weeks treatment of Huaier granule
Time frame: 16 weeks
Reduction rate of targeted drugs after 8 weeks treatment of Huaier granule
Proportion of subjects with VEGFR-TKIs drug reduction after 8 weeks treatment of Huaier granule.
Time frame: 8 weeks
Reduction rate of targeted drugs after 16 weeks treatment of Huaier granule
Proportion of subjects with VEGFR-TKIs drug reduction after 16 weeks treatment of Huaier granule.
Time frame: 16 weeks
Discontinuation rate of targeted drugs after 8 weeks treatment of Huaier granule
Proportion of subjects with VEGFR-TKIs drug discontinuation after 8 weeks treatment of Huaier granule.
Time frame: 8 weeks
4. Discontinuation rate of targeted drugs after 16 weeks treatment of Huaier granule
Proportion of subjects with VEGFR-TKIs drug discontinuation after 16 weeks treatment of Huaier granule.
Time frame: 16 weeks
ORR
Objective response rate: proportion of subjects who achieved complete remission (CR) or partial remission (PR) by primary tumor imaging evaluation.
Time frame: 24 weeks
DCR
Disease control rate: proportion of subjects who achieved complete remission (CR) or partial remission (PR) or stable disease (SD) by primary tumor imaging evaluation.
Time frame: 24 weeks
PFS
Progression free survival: time from the date when the subject first received targeted therapy he was receiving at the time of enrollment to the first observation of tumor progression or death from any cause.
Time frame: 24 weeks
Plan to share: No
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