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Early Management for Anti-Angiogenic Drug-Related Proteinuria in Hepatocellular Carcinoma: A Prospective, Randomized, Controlled Study Aimed at Maintaining Targeted Therapy Intensity and Improving Prognosis

Early Management for Anti-Angiogenic Drug-Related Proteinuria in Hepatocellular Carcinoma: A Prospective, Randomized, Controlled Study Aimed at Maintaining Targeted Therapy Intensity and Improving Prognosis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600128727
Enrollment
Unknown
Registered
2026-07-24
Start date
2026-08-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver cancer

Interventions

Standard management group:Follow the current clinical routine, which is to do a 24-hour urine protein test only if the urine protein qualitative test is >= 2, and then decide whether to pause targeted
Early active intervention group and Standard management group:When a qualitative urine protein test shows >=1 (or the urine protein/creatinine ratio is >=200 mg/g), the planned intervention should be

Sponsors

Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Aged >=18, =3 months; 6.Signed informed consent form.

Exclusion criteria

Exclusion criteria: 1. Pre-existing clinically significant proteinuria (urine protein =1g/24h); 2. Known severe chronic kidney disease (eGFR <60 mL/min/1.73 m²) or need for dialysis; 3. Uncontrolled high blood pressure (systolic =150mmHg or diastolic =100mmHg even after antihypertensive treatment); 4. Use of ACE inhibitors, angiotensin II receptor blockers, or other renin-angiotensin system inhibitors within 4 weeks before the study begins; 5. Having other active malignant tumors; 6. History of kidney transplant; 7. History of asthma; 8. Having long-term cough symptoms; 9. Women who are pregnant or breastfeeding.

Design outcomes

Primary

MeasureTime frame
Incidence of dose reduction or interruption of targeted drugs due to proteinuria within one year;

Secondary

MeasureTime frame
Time until clinically significant proteinuria occurs;Changes in kidney function (creatinine, eGFR) compared to baseline;Relative dose intensity of targeted drugs within 1 year;Progression-free survival, overall survival;The occurrence and severity of adverse events (graded according to CTCAE 5.0);

Countries

China

Contacts

Public ContactZhouping Zou

Zhongshan Hospital, Fudan University

zouzhouping520@163.com+86 21 64041990

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026