Hepatocellular Carcinoma
Conditions
Keywords
Hepatocellular Carcinoma, carbon-ion radiotherapy, GM-CSF, immunotherapy
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.
Interventions
RADIATIONcarbon-ion radiotherapy
Hypofractionated carbon-ion radiotherapy was prescribed at a dose of 40Gy RBE in 5 fractions
Sponsors
Shanghai Proton and Heavy Ion Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. 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; 2. no clinically distant metastasis; 3. the tumor is away from gastro-intestinal (GI) tract (\>1cm); 4. Child Push score A,technically unresectable, or medically inoperable; maximal tumor size is less than 10 cm; 5. age ≥ 18 and \<80 years of age; 6. Karnofsky Performance Score ≥ 70; 7. 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; 8. Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial;
Exclusion criteria
1. Distant metastasis (M1); 2. maximal tumor size is more than 10 cm; 3. tumor invading adjacent gastrointestine (T4); 4. Child push score B or C; 5. Previous hepatic radiotherapy; 6. Severe systemic disorders; 7. 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; 8. Non conformity of the radiotherapy dose distribution when compared to the dose constraints; 9. Psychiatric disorders or any other condition that can make unreliable the informed consent;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
China
Outcome results
None listed