Trials / Withdrawn
WithdrawnNCT05592197
Safety and Efficacy of Radiation Plus TACE and Lenvatinib in Advanced HCC With PVTT
Safety and Efficacy of External Beam Radiation Plus Transarterial Chemoembolization and Lenvatinib vs Transarterial Chemoembolization and Lenvatinib in Advanced Hepatocellular Carcinoma With Portal Vein Tumor Thrombus
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Sun Yat-sen University · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This is a multicentri prospective cohort study to investigate the safety and efficacy of external beam radiation (RT) combined with transarterial chemoembolization (TACE) and lenvatinib vs TACE and lenvatinib in the treatment of advanced hepatocellular carcinoma (HCC) with portal vein tumor thrombus (PVTT).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lenvatinib | Lenvatinib will be initially provided to patients first (dose: 8 mg qd for patients \< 60 kg, and 12 mg qd for patients ≥ 60 kg) |
| PROCEDURE | TACE | TACE will be performed one day after oral administration of lenvatinib. Either cTACE or DEB-TACE can be used, depending on the condition of each center. |
| RADIATION | External beam radiation (RT) | RT will be given within 4 weeks after the first TACE with linear accelerator-based photon beams. Gross tumor volume is defined as intrahepatic tumor and vascular invasion including a 1-cm margin into the contiguous HCC. Prescription dose will be 4500-6000 cGy in 25 fractions. |
Timeline
- Start date
- 2018-10-01
- Primary completion
- 2023-03-01
- Completion
- 2023-03-01
- First posted
- 2022-10-24
- Last updated
- 2023-02-16
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05592197. Inclusion in this directory is not an endorsement.