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

Sponsor

Shanghai Proton and Heavy Ion Center (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02946138

Collaborator

(none)

Enrollment

Locations

Arm

Actual Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma	Radiation: carbon-ion radiotherapy	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 1, 2016

Anticipated Primary Completion Date :

Aug 1, 2019

Actual Study Completion Date :

Aug 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: carbon-ion radiotherapy with GM-CSF Hypofractionated carbon-ion radiotherapy was prescribed at a dose of 40Gray(Gy) [relative biological effectiveness (RBE)] in 5 fractions for intrahepatic cases away from gastro-intestinal (GI) tract (>1cm) with concurrent GM-CSF 125ug/m2/d, subcutaneous injection d1-28;	Radiation: carbon-ion radiotherapy Hypofractionated carbon-ion radiotherapy was prescribed at a dose of 40Gy RBE in 5 fractions

Arm

Intervention/Treatment

Experimental: carbon-ion radiotherapy with GM-CSF

Hypofractionated carbon-ion radiotherapy was prescribed at a dose of 40Gray(Gy) [relative biological effectiveness (RBE)] in 5 fractions for intrahepatic cases away from gastro-intestinal (GI) tract (>1cm) with concurrent GM-CSF 125ug/m2/d, subcutaneous injection d1-28;

Radiation: carbon-ion radiotherapy

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

Outcome Measures

Primary Outcome Measures

Progression-free survival of all patients [2 year]
Time in months measured from treatment initiation until the date of progression or the date of last follow-up.

Secondary Outcome Measures

Overall Survival [2 year]
Time in months measured from treatment initiation until the date of death or the date of last follow-up.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [Time interval from the start of carbon-ion radiotherapy to 3 months after the completion of carbon-ion radiotherapy]]
Objective responses rate [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

histologically confirmed hepatocellular carcinoma (HCC) or clinical diagnosis of HCC according to American association for the study of liver diseases （AASLD）-guidelines or clinical diagnosis criteria based on Alpha Fetoprotein （AFP), and radiological images proposed by Liver Cancer Society, Chinese Anti-Cancer Association;
no clinically distant metastasis;
the tumor is away from gastro-intestinal (GI) tract (>1cm);
Child Push score A,technically unresectable, or medically inoperable; maximal tumor size is less than 10 cm;
age ≥ 18 and <80 years of age;
Karnofsky Performance Score ≥ 70;
No previous invasive cancer (within 5 years before the HCC diagnosis)except for skin non-melanoma cancer or non muscle invasive bladder cancer; Ability to understand character and individual consequences of the clinical trial;
Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial;

Exclusion Criteria:

Distant metastasis (M1);
maximal tumor size is more than 10 cm;
tumor invading adjacent gastrointestine (T4);
Child push score B or C;
Previous hepatic radiotherapy;
Severe systemic disorders;
Previous malignancy (within 5 years) except for skin non-melanoma cancer or 3-year disease free interval from previous malignancy like in situ cervix cancer or non muscle invasive bladder cancer;
Non conformity of the radiotherapy dose distribution when compared to the dose constraints;
Psychiatric disorders or any other condition that can make unreliable the informed consent;