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A prospective randomized controlled clinical study of the efficacy of lenvatinib combined with TACE versus TACE alone in patients with advanced first-line unresectable hepatitis B infection

A prospective randomized controlled clinical study of the efficacy of lenvatinib combined with TACE versus TACE alone in patients with advanced first-line unresectable hepatitis B infection

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033343
Enrollment
Unknown
Registered
2020-05-28
Start date
2020-06-30
Completion date
Unknown
Last updated
2020-06-01

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

Conditions

Hepatocellular carcinoma

Interventions

experimental group:Lenvatinib combined with TACE

Sponsors

The First Affiliated Hospital of Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. The patients who have no history of targeted drug therapy such as sorafenib and lovatinib, and no history of lovatinib allergy agree to receive lovatinib and TACE treatment; 2. Patients with HBsAg positive for more than 3 months; 3. Patients with unresectable liver cancer who have not received other systematic treatment in the late stage; 4. Patients older than 18 and younger than 75; 5. Patients with good blood pressure control (= 6 months; 9. The functions of blood, liver and kidney meet the following conditions: (discharge standard) Neutrophil count >= 1.5 x 10^9 / L. Platelet count >= 75 x 10^9 / L. Hemoglobin concentration >= 8.5g/dl. Serum albumin concentration >= 2.8g/dl. Bilirubin is 3 times lower than the normal upper limit. AST and ALT were 5 times lower than the normal upper limit, ALP was 4 times lower than the normal upper limit. The prothrombin time was prolonged within 6 seconds. Creatinine was 1.5 times lower than the normal upper limit.

Exclusion criteria

Exclusion criteria: 1. Patients whose liver occupied more than 50% of the liver volume; 2. Patients with liver cancer invading the main portal vein or inferior vena cava; 3. Patients with rupture and bleeding of liver cancer; 4. Patients with extrahepatic metastasis of liver cancer; 5. Patients with previous history of hepatic encephalopathy, refractory ascites or gastroesophageal varices; 6. Patients with contraindications to TACE, such as portosystemic shunt, extrahepatic blood flow, obvious atherosclerosis; 7. Patients who are allergic to intravenous contrast media; 8. Pregnant or lactating women or subjects with family planning within two years; 9. Patients with HIV and syphilis infection; 10. Patients with other malignancies or with other malignancies within 5 years before admission; 11. Patients with severe cardiac, renal and other organ dysfunction; 12. Patients with active clinical severe infection > Level 2 (NCI-CTC version 4); 13. Patients with mental disorders may affect informed consent; 14. Patients unable to take oral medicine; 15. Patients who participated in clinical trials of other drugs within 12 months before admission.

Design outcomes

Primary

MeasureTime frame
TTUP;

Secondary

MeasureTime frame
PFS;OS;ORR;quality-of-life measurements;

Countries

China

Contacts

Public ContactChunhui Nie

The First Affiliated Hospital of Zhejiang University

sunjh121@163.com+86 15990155409

Outcome results

None listed

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