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Trial Title:
Effect of Huaier Granule on Nephrotoxicity Associated With Targeted Therapy for Advanced Hepatobiliary Malignancies.
NCT ID:
NCT05673824
Condition:
Nephrotoxicity
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
Huaier granule
proteinuria
hepatobiliary malignancies
anti-angiogenesis targeted therapy
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Huaier Granule
Description:
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.
Arm group label:
Huaier Granule Group
Intervention type:
Drug
Intervention name:
VEGFR-TKIs
Description:
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.
Arm group label:
Huaier Granule Group
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.
Detailed description:
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Lu Wang
Start date:
February 7, 2023
Completion date:
April 30, 2025
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Collaborator:
Agency:
LinkDoc Technology (Beijing) Co. Ltd.
Agency class:
Industry
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05673824