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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Huaier Granule | Drug | Take orally, 10g each time, three times daily. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Start of treatment until 16-week follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Start of treatment until 48-week follow-up |
| 48-week Resumption and Discontinuation Rates for Bevacizumab or Anlotinib after Proteinuria Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jialei Wang, phD | Contact | 0086-18017312369 | luwangjialei@126.com | |
| Xinmin Zhao, phD | Contact | 0086-18017312493 |
| Name | Affiliation | Role |
|---|---|---|
| Jialei Wang, phD | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuzhou Central Hospital | Xuzhou | Jiangsu | China |
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| Anlotinib and Bevacizumab |
| Drug |
Administer according to clinical routine practice. Refer to the respective drug prescribing information for specific usage. |
|
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. |
| 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 | Start of treatment until 48-week follow-up |
| Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | China |
|
| ID | Term |
|---|---|
| D011507 | Proteinuria |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000625192 | anlotinib |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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