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

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04791176 on ClinicalTrials.gov