Back to resultsPhase II Trial of Carbon-ion Radiotherapy Combined With GM-CSF for the Treatment of Hepatocellular Carcinoma
Primary Purpose
Hepatocellular Carcinoma
Status
Withdrawn
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
carbon-ion radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular Carcinoma, carbon-ion radiotherapy, GM-CSF, immunotherapy
Eligibility Criteria
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;
Sites / Locations
- Shanghai Proton and Heavy Ion Center
- Shanghai Proton and Heavy Ion Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
carbon-ion radiotherapy with GM-CSF
Arm Description
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;
Outcomes
Primary Outcome Measures
Progression-free survival of all patients
Time in months measured from treatment initiation until the date of progression or the date of last follow-up.
Secondary Outcome Measures
Overall Survival
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
Objective responses rate
Full Information
NCT ID
NCT02946138
First Posted
October 25, 2016
Last Updated
September 5, 2019
Sponsor
Shanghai Proton and Heavy Ion Center
1. Study Identification
Unique Protocol Identification Number
NCT02946138
Brief Title
Phase II Trial of Carbon-ion Radiotherapy Combined With GM-CSF for the Treatment of Hepatocellular Carcinoma
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Withdrawn
Why Stopped
enrollment was too slow
Study Start Date
October 2016 (Actual)
Primary Completion Date
August 2019 (Anticipated)
Study Completion Date
August 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Proton and Heavy Ion Center
4. Oversight
Data Monitoring Committee
Yes
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Hepatocellular Carcinoma, carbon-ion radiotherapy, GM-CSF, immunotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
carbon-ion radiotherapy with GM-CSF
Arm Type
Experimental
Arm Description
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;
Intervention Type
Radiation
Intervention Name(s)
carbon-ion radiotherapy
Intervention Description
Hypofractionated carbon-ion radiotherapy was prescribed at a dose of 40Gy RBE in 5 fractions
Primary Outcome Measure Information:
Title
Progression-free survival of all patients
Description
Time in months measured from treatment initiation until the date of progression or the date of last follow-up.
Time Frame
2 year
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Time in months measured from treatment initiation until the date of death or the date of last follow-up.
Time Frame
2 year
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame
Time interval from the start of carbon-ion radiotherapy to 3 months after the completion of carbon-ion radiotherapy]
Title
Objective responses rate
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
guo-liang jiang, Dr.
Organizational Affiliation
Shanghai Proton and Heavy Ion Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Proton and Heavy Ion Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201321
Country
China
Facility Name
Shanghai Proton and Heavy Ion Center
City
Shanghai
ZIP/Postal Code
201321
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Phase II Trial of Carbon-ion Radiotherapy Combined With GM-CSF for the Treatment of Hepatocellular Carcinoma
We'll reach out to this number within 24 hrs