NCT02802124

Carbon Ion Radiotherapy for the Treatment of Chinese Hepatocellular Carcinoma

Phase I Trial Evaluating Carbon Ion Radiotherapy for the Treatment of Chinese Hepatocellular Carcinoma

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (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 feasibility and safety of carbon-ion radiotherapy for the treatment of localized Chinese hepatocellular carcinoma

Detailed description

The purpose of this study is to determine the maximal tolerated dose (MTD) of carbon ion radiotherapy (CIRT) in the treatment of localized Chinese hepatocellular carcinoma with respective to toxicity and tumor control. Participants will be treated with CIRT with escalating dose regimens based on the tumor location to evaluate the maximal tolerated dose (MTD) in terms of acute and subacute toxicity observed during and within 3 months after the completion of CIRT. Primary endpoint is toxicity, second endpoint is progression-free survival, overall survival and tumor response.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
RADIATION	carbon-ion radiotherapy for tumor away from GI
RADIATION	carbon-ion radiotherapy for tumor adjacent to GI

Timeline

• Start date: 2015-06-01
• Primary completion: 2023-10-01
• Completion: 2023-10-01
• First posted: 2016-06-16
• Last updated: 2023-12-07

Locations

1 site across 1 country: China