ProteinuriaPhase 4NCT07358520
Clinical Study on the Use of Huaier Granules for the Treatment of Proteinuria Related to Bevacizumab and Anlotinib in Lung Cancer Patients
A Phase 4 study testing Huaier Granule and Anlotinib and Bevacizumab in people with Proteinuria, run by Fudan University at 2 sites in China.
Trial summary
This study is a prospective, multicenter, parallel-controlled clinical trial designed to evaluate the therapeutic efficacy of Huaier Granules for proteinuria occurring in lung cancer patients undergoing treatment with either Bevacizumab or Anlotinib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proteinuria
- What is being tested?
- Huaier Granule and Anlotinib and Bevacizumab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesChina
- Study dates
- 28 Jan 2026to 28 Jan 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years;
- Histopathologically confirmed diagnosis of lung cancer;
- Receiving Bevacizumab or Anlotinib treatment;
- Positive urine protein detection, with 0.15g < 24-hour urinary protein quantification < 3.5g;
- No treatment with Huaier Granules within one month prior to enrollment;
- Expected survival time not less than 6 months;
- Voluntary participation in this study and provision of signed informed consent.
Who cannot join
- Known allergy, contraindication, or caution to any component of Huaier Granules;
- Inability to take oral medication;
- Required or ongoing use of drugs known to potentially affect proteinuria, including but not limited to ACE inhibitors, glucocorticoids (>3 weeks), and Chinese patent medicines (as per respective drug prescribing information);
- Proteinuria caused by underlying diseases, including but not limited to nephropathy, hypertension, urinary tract infection, systemic lupus erythematosus, multiple myeloma, etc.;
- Women who are pregnant, breastfeeding, or planning pregnancy;
- Currently participating in other clinical trials investigating drugs for treating proteinuria;
- Refusal to cooperate with follow-up;
- Any other reasons deemed by the investigator as unsuitable for participation in this study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Xinmin Zhao, phD contact
China2 sites
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
Fengfeng Han, phD, 0086-13816386372, fengfhan86@sina.com
Xuzhou Central Hospital
Xuzhou, Jiangsu
Xiang Wang, phD, 0086-18912007930, XiangWang7726@163.com
About this study
Official title: Prospective, Multicenter, Parallel-Controlled Clinical Study on the Use of Huaier Granules for the Treatment of Bevacizumab- and Anlotinib-Related Proteinuria in Lung Cancer Patients
This study is a prospective, multicenter, parallel-controlled clinical trial designed to evaluate the therapeutic efficacy of Huaier Granules for proteinuria occurring in lung cancer patients undergoing treatment with either Bevacizumab or Anlotinib.
Read the detailed description
This study is a prospective, multicenter, parallel-controlled exploratory trial. It plans to enroll 40 subjects diagnosed with malignant lung tumors, who will visit the selected research centers from October 2025 to October 2026. All subjects will be assigned to either the control group or the experimental group based on clinical management and their own preference. Subjects in the control group will receive no therapeutic intervention, while those in the experimental group will be administered Huaier Granules.Throughout the study period, the planned duration for subject recruitment and enrollment is 12 months. The total follow-up duration for enrolled subjects is 48 weeks. After enrollment, subjects will be followed up every 2 weeks during the first 8 weeks, and then every 4 weeks thereafter. Follow-ups will continue until the study ends, the subject withdraws from the study for any reason, is lost to follow-up, or dies, whichever occurs first.
- Conditions
- Proteinuria
- Being tested
- Huaier Granule, Anlotinib and Bevacizumab
- Keywords
- Huaier Granules, Proteinuria, Bevacizumab, Anlotinib
- Medical subject headings
- Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Huaier GranuleDrug
Take orally, 10g each time, three times daily.
Anlotinib and BevacizumabDrug
Administer according to clinical routine practice. Refer to the respective drug prescribing information for specific usage.
| Study group | Role | What they receive |
|---|---|---|
| Huaier Granules | Experimental | Take orally, 10g each time, three times a day. Participants in the experimental group should continue treatment for at least 24 weeks or until treatment failure, intolerable toxicity, withdrawal from the study for any reason, or death, whichever occurs first; or until the investigator determines that there is no further benefit. For specific usage, refer to the drug instructions. Receives: Drug: Huaier Granule |
| Anlotinib and Bevacizumab | Active comparator | Administer according to clinical routine practice. Refer to the respective drug prescribing information for specific usage. Continue treatment until disease progression, intolerable toxicity, withdrawal from the study for any reason, or death, whichever occurs first. Receives: Drug: Anlotinib and Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
16-week Efficacy Rate for Proteinuria Treatment
It defined as the proportion of subjects achieving complete remission, partial remission, or stable disease according to proteinuria treatment efficacy evaluation at 16 weeks, relative to the total number of subjects in both groups.
Measured: Start of treatment until 16-week follow-up
Secondary outcomes (3)
48-week Recurrence Rate for Proteinuria Treatment
It defined as the proportion of subjects whose proteinuria reverts to positive (≥1+) after becoming negative during treatment, relative to the total number of subjects.
Measured: Start of treatment until 48-week follow-up
48-week Resumption and Discontinuation Rates for Bevacizumab or Anlotinib after Proteinuria Treatment
It defined as the proportion of subjects who, due to worsening proteinuria, required temporary suspension of bevacizumab or anlotinib and subsequently resumed treatment after proteinuria alleviation, relative to the total number of subjects.
Measured: Start of treatment until 48-week follow-up
Incidence and Severity of Other Adverse Reactions (including but not limited to hypertension, bleeding, and gastrointestinal perforation) after 48 weeks of Proteinuria Treatment
Incidence is defined as the proportion of subjects experiencing other adverse reactions (including but not limited to hypertension, bleeding, and gastrointestinal perforation) relative to the corresponding total population. Severity will be assessed as per the relevant descriptions in the adverse event definitions and evaluation section
Measured: Start of treatment until 48-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start28 Jan 2026 (estimated)
- Primary completion28 Jan 2027 (estimated)
- Study completion28 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProteinuriaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jialei Wang, Fudan University
- Investigators
- Jialei Wang, phD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07358520
- Sponsor's protocol ID
- HE-202508
- Status last verified
- Jan 2026
- First submitted
- 14 Jan 2026
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Parallel-Controlled Clinical Study on the Use of Huaier Granules for the Treatment of Bevacizumab- and Anlotinib-Related Proteinuria in Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT07358520
- Acronym / sponsor ID
- HE-202508
- Conditions
- Proteinuria
- Keywords
- Huaier Granules, Proteinuria, Bevacizumab, Anlotinib
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 28 Jan 2026 (estimated)
- Primary completion
- 28 Jan 2027 (estimated)
- Study completion
- 28 Jan 2028 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a prospective, multicenter, parallel-controlled clinical trial designed to evaluate the therapeutic efficacy of Huaier Granules for proteinuria occurring in lung cancer patients undergoing treatment with either Bevacizumab or Anlotinib.
Detailed description
This study is a prospective, multicenter, parallel-controlled exploratory trial. It plans to enroll 40 subjects diagnosed with malignant lung tumors, who will visit the selected research centers from October 2025 to October 2026. All subjects will be assigned to either the control group or the experimental group based on clinical management and their own preference. Subjects in the control group will receive no therapeutic intervention, while those in the experimental group will be administered Huaier Granules.Throughout the study period, the planned duration for subject recruitment and enrollment is 12 months. The total follow-up duration for enrolled subjects is 48 weeks. After enrollment, subjects will be followed up every 2 weeks during the first 8 weeks, and then every 4 weeks thereafter. Follow-ups will continue until the study ends, the subject withdraws from the study for any reason, is lost to follow-up, or dies, whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Huaier Granules | Experimental | Drug: Huaier GranuleTake orally, 10g each time, three times a day. Participants in the experimental group should continue treatment for at least 24 weeks or until treatment failure, intolerable toxicity, withdrawal from the study for any reason, or death, whichever occurs first; or until the investigator determines that there is no further benefit. For specific usage, refer to the drug instructions. |
| Anlotinib and Bevacizumab | Active comparator | Drug: Anlotinib and BevacizumabAdminister according to clinical routine practice. Refer to the respective drug prescribing information for specific usage. Continue treatment until disease progression, intolerable toxicity, withdrawal from the study for any reason, or death, whichever occurs first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years;
- Histopathologically confirmed diagnosis of lung cancer;
- Receiving Bevacizumab or Anlotinib treatment;
- Positive urine protein detection, with 0.15g < 24-hour urinary protein quantification < 3.5g;
- No treatment with Huaier Granules within one month prior to enrollment;
Key exclusion criteria (8 listed)
- Known allergy, contraindication, or caution to any component of Huaier Granules;
- Inability to take oral medication;
- Required or ongoing use of drugs known to potentially affect proteinuria, including but not limited to ACE inhibitors, glucocorticoids (>3 weeks), and Chinese patent medicines (as per respective drug prescribing information);
- Proteinuria caused by underlying diseases, including but not limited to nephropathy, hypertension, urinary tract infection, systemic lupus erythematosus, multiple myeloma, etc.;
- Women who are pregnant, breastfeeding, or planning pregnancy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Huaier GranuleTake orally, 10g each time, three times daily. | Drug | Huaier Granules |
| Anlotinib and BevacizumabAdminister according to clinical routine practice. Refer to the respective drug prescribing information for specific usage. | Drug | Anlotinib and Bevacizumab |
Primary outcome
16-week Efficacy Rate for Proteinuria Treatment
Time frame: Start of treatment until 16-week follow-up
It defined as the proportion of subjects achieving complete remission, partial remission, or stable disease according to proteinuria treatment efficacy evaluation at 16 weeks, relative to the total number of subjects in both groups.
3 secondary outcomes
48-week Recurrence Rate for Proteinuria Treatment
Time frame: Start of treatment until 48-week follow-up
48-week Resumption and Discontinuation Rates for Bevacizumab or Anlotinib after Proteinuria Treatment
Time frame: Start of treatment until 48-week follow-up
Incidence and Severity of Other Adverse Reactions (including but not limited to hypertension, bleeding, and gastrointestinal perforation) after 48 weeks of Proteinuria Treatment
Time frame: Start of treatment until 48-week follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xinmin Zhao, phD contact
Jialei Wang, phD principal investigator
Fudan University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Huaier Granule and Anlotinib and Bevacizumab in people with Proteinuria, run by Fudan University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jialei Wang, phD (0086-18017312369, luwangjialei@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
16-week Efficacy Rate for Proteinuria Treatment (time frame: Start of treatment until 16-week follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.