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Herbal granule shows promise in easing kidney harm from cancer drugs

NCT ID NCT05673824

Symptom relief Sponsor: Fudan University Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether Huaier Granule, a traditional Chinese medicine, can reduce protein in the urine—a sign of kidney damage—caused by anti-angiogenesis targeted therapy in 76 adults with advanced liver or bile duct cancer. Participants took the granule for 8 weeks, and researchers measured changes in urine protein levels. The goal was to see if the treatment could ease this side effect without curing the cancer itself.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

76 people

The number who actually took part.

Started

Jan 2023

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

hepatobiliary neoplasm proteinuria

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Nephrotoxicity

Contacts and locations

Locations

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, China

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