Phase II Study of Concurrent Lenvatinib and Radiotherapy for Advanced HCC
NCT04791176 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64
Last updated 2025-08-14
Summary
This is a single-arm, open-label study performed at our hospital, patients with progression hepatocellular carcinoma (HCC) met inclusion criteria will be enrolled. Patients received oral lenvatinib 12mg/day (for patients≥60 kg) or 8 mg/day (for patients\<60kg ) before local radiotherapy 4 weeks, large lesions were treated with IMRT for 40-60gy / 20-30f. Combined therapy will be taken until unacceptable treatment-related toxicities occurred or disease progression.
Conditions
- Hepatocellular Carcinoma
- Radiotherapy
- Lenvatinib
Interventions
- RADIATION
-
concurrent lenvatinib and Radiotherapy, followed lenvatinib maintenance
Radiotherapy with IMRT or VMAT with 40-60Gy/20-30f; Concurrent Lenvatinib 12mg/day (for patients≥60 kg) or 8 mg/day (for patients\<60kg ) qd po. (Note: Levatinib can be given to patients in four weeks before Radiotherapy is applied, so that it can control disease during waiting for Radiotherapy). Maintenance Lenvatinib 12mg/day (for patients≥60 kg) or 8 mg/day (for patients\<60kg ) qd po until disease progress or unacceptable adverse events; six months is recommended but not mandatory.
Sponsors & Collaborators
-
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-04-12
- Primary Completion
- 2024-06-30
- Completion
- 2025-05-23
Countries
- China
Study Locations
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