Effect of Huaier Granule on Nephrotoxicity Associated With Targeted Therapy for Advanced Hepatobiliary Malignancies.

NCT05673824 | Completed Phase 2

• 1 other identifier: HE-202210
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nephrotoxicity

Keywords

Huaier granule; proteinuria; hepatobiliary malignancies; anti-angiogenesis targeted therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks

Secondary Outcomes (6)

• Mean value of 24-hour urinary protein level change from baseline to 8 weeks treatment of Huaier granule

  8 weeks

• Mean value of 24-hour urinary protein level decrease rate from baseline to 8 weeks treatment of Huaier granule

  8 weeks

• Incidence and severity of renal adverse events (AE) after 8 weeks treatment of Huaier granule

  8 weeks

• Incidence and severity of serious renal adverse events (SAE) after 8 weeks treatment of Huaier granule

  8 weeks

• Incidence and severity of renal adverse events (AE) after 16 weeks treatment of Huaier granule

  16 weeks

Other Outcomes (7)

• Reduction rate of targeted drugs after 8 weeks treatment of Huaier granule

  8 weeks

• Reduction rate of targeted drugs after 16 weeks treatment of Huaier granule

  16 weeks

• Discontinuation rate of targeted drugs after 8 weeks treatment of Huaier granule

  8 weeks

Study Arms (1)

Huaier Granule Group

EXPERIMENTAL

Huaier Granule+VEGFR-TKIs

Drug: Huaier Granule; Drug: VEGFR-TKIs

Interventions

Huaier Granule DRUG

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.

Huaier Granule Group

VEGFR-TKIs DRUG

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.

Huaier Granule Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Volunteer to join the study and sign the informed consent form.

You may not qualify if:

• 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.
• Pregnant or lactating women or women prepare for pregnancy.
• Participating in clinical trials of other drugs that intend to treat proteinuria.
• Refused to cooperate with follow-up.
• Other reasons that the researcher considers unsuitable to participate in this study.

Sponsors & Collaborators

• Fudan University: lead
• LinkDoc Technology (Beijing) Co. Ltd.: collaborator

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Proteinuria

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lu Wang

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: January 6, 2023
• Study Start: January 3, 2023
• Primary Completion: September 16, 2025
• Study Completion: December 1, 2025
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)