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TACE plus Lenvatinib versus TACE Plus Sorafenib for Unresectable Hepatocellular Carcinoma with Portal Vein Tumor Thrombus

TACE plus Lenvatinib versus TACE Plus Sorafenib for Unresectable Hepatocellular Carcinoma with Portal Vein Tumor Thrombus

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046490
Enrollment
Unknown
Registered
2021-05-16
Start date
2017-09-01
Completion date
Unknown
Last updated
2022-01-04

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

Conditions

Liver Cancer

Interventions

TACE+Lenvatinib:Lenvatinib
TACE+Sorafenib:Sorafenib

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
23 Years to 72 Years

Inclusion criteria

Inclusion criteria: 1. Patients with primary or recurrent HCC who strictly comply with the clinical diagnostic criteria of the code for the diagnosis and treatment of primary liver cancer (version 2019) or confirmed by histopathology or cytology, and who are unable to accept palliative surgery and do not reach the bclc-c level; 2. Did not receive any systemic treatment; 3. The level of child Pugh A / B; 4. According to mrecist1.1, there were measurable lesions; 5. Aged 18 to 75 years; 6. ECoG physical condition 0-1; 7. Total bilirubin 1500 / uL; 10. Platelet > 75000 / uL; 11. Serum uric acid =2.8 g/dl; 14. Prothrombin time (PT) - international normalized ratio (INR): PT < reference value + 6 seconds or INR < 1.7; 15. Subjects with active hepatitis B or C can receive antiviral drugs other than interferon.

Exclusion criteria

Exclusion criteria: 1. Severe infections requiring systemic antibiotic treatment occurred at enrollment or within 7 days before the first administration; 2. Pregnancy or lactation; 3. Poor compliance is expected; 4. Uncontrollable diseases include (but are not limited to): ongoing or active infection, symptomatic congestive heart failure (NYHA standard, grade III or IV), arrhythmia, and mental illness; 5. Subjects who had received any anti-cancer treatment before entering the study and did not return to baseline (except for alopecia) or 5% bone marrow area) within 4 weeks before participating in the study.

Design outcomes

Primary

MeasureTime frame
Overall survival;Progression free survival;

Secondary

MeasureTime frame
response rate;Adverse events rate;

Countries

China

Contacts

Public ContactBiao Yang

West China Hospital, Sichuan University

landayb@163.com+86 18428396750

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026