Carbon Ion Radiotherapy for the Treatment of Chinese Hepatocellular Carcinoma
Hepatocellular Carcinoma
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring hepatocellular carcinoma, carbon-ion radiotherapy, toxicity, efficacy
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;
- Child Push score A,technically unresectable, or medically inoperable; maximal tumor size is less than 12 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 12 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 CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
carbon-ion radiotherapy for tumor away from GI
carbon-ion radiotherapy for tumor adjacent to GI
For tumor location which is away from gastrointestine (the distance is more than 1 cm). We use carbon-ion radiotherapy for the treatment of hepatocellular carcinoma. Four dose levels [55 Gray equivalent (GyE)/10 fractions (Fx), 60GyE/10Fx, 65GyE/10Fx, 70GyE/10Fx] are planned within the Phase I part.
For tumor location which is adjacent to gastrointestine (less than 1 cm).We use carbon-ion radiotherapy for the treatment of hepatocellular carcinoma. Three dose levels (carbon 60GyE/15Fx, carbon 67.5GyE/15Fx, carbon 75GyE/15Fx) are planned within the Phase I part.