NCT02946138

Phase II Trial of Carbon-ion Radiotherapy Combined With GM-CSF for the Treatment of Hepatocellular Carcinoma

A Prospective Phase II Single-institution Trial of Carbon-ion Radiotherapy Combined With Granulocyte-macrophage Colony-stimulating Factor for the Treatment of Hepatocellular Carcinoma

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Shanghai Proton and Heavy Ion Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The aim of this research project is to assess the efficacy and toxicity of hypofractionated carbon-ion radiotherapy with concurrent granulocyte-macrophage colony-stimulating factor for the treatment of hepatocellular carcinoma

Detailed description

Golden E.B. et al.in 2015 reported that localized radiotherapy granulocyte-macrophage colony-stimulating factor (GM-CSF) produced objective abscopal responses in solid tumor with metastasises. We hypothesize that hypofractionated carbon-ion radiotherapy combining granulocyte-macrophage colony-stimulating factor (GM-CSF) might improve the clinical response rate and progression-free survival (PFS) in hepatocellular carcinoma. The primary endpoint of the current phase II trial is progression-free survival rate at 2 years, secondary endpoints are overall survival, safety and toxicity.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
RADIATION	carbon-ion radiotherapy	Hypofractionated carbon-ion radiotherapy was prescribed at a dose of 40Gy RBE in 5 fractions

Timeline

• Start date: 2016-10-01
• Primary completion: 2019-08-01
• Completion: 2019-08-01
• First posted: 2016-10-27
• Last updated: 2019-09-09

Locations

2 sites across 1 country: China