NCT04791176

Phase II Study of Concurrent Lenvatinib and Radiotherapy for Advanced HCC

Phase II Study of Concurrent Lenvatinib and Intensity-modulated Radiotherapy (IMRT) for Advanced Hepatocellular Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2021-04-12
• Primary completion: 2024-06-30
• Completion: 2025-05-23
• First posted: 2021-03-10
• Last updated: 2025-08-14

Locations

1 site across 1 country: China