Personalized Adaptive Radiotherapy for Hepatocellular Carcinoma

Korábbi kezelés

• Any previous RT to the abdomino-pelvic region that would result in significant overlap of RT volume for the current study.
• Participants must not be receiving any other standard anti-cancer therapy or experimental agent concurrently with PULSAR.

Más betegség

• History of liver transplantation
• Individuals with severe, active co-morbidity including any of the following: Chronic obstructive pulmonary disease or other pulmonary illness requiring hospitalization within 30 days of study registration, Unstable angina and/or congestive heart failure requiring hospitalization within the 30 days of study registration, Acute myocardial infarction within 30 days of study registration, Diseases precluding RT (e.g., active scleroderma, lupus or inflammatory bowel disease)

• Diagnosis of HCC by at least 1 criterion: pathologically (histologically or cytologically) proven diagnosis of HCC, Radiographically proven diagnosis of HCC by multiphasic MRI and/or CT scan (arterial enhancement and delayed washout)
• One to five discrete intrahepatic parenchymal foci of HCC: Total maximal sum of intrahepatic parenchymal HCC tumors, as a single conglomerate, multiple lesions, or infiltrative HCC <10 cm in total summed diameter, HCC macrovascular invasion is permitted, Presence of extrahepatic metastatic disease is permitted, No direct primary tumor extension into the stomach, duodenum, small bowel, or large bowel.
• Patients must be Child-Pugh score B8-9
• In the investigator's opinion, patient is unsuitable for radical intent SBRT (i.e., ablative radiation dose over one to two weeks), or SBRT as bridge to liver transplant.
• Unsuitable for or refractory to standard local therapies, such as liver transplant, resection, radiofrequency ablation (RFA), or TACE.
• Unsuitable for TARE.
• Unsuitable for, high risk for, or refractory to, standard systemic therapy.
• Must be ≥ 18 years of age.
• Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Life expectancy > 3 months.
• Blood work obtained within 14 days prior to randomization as follows: Hemoglobin > 80 g/L (Note: The use of transfusion or other intervention to achieve Hgb ≥ 80g/L is acceptable), Platelets > 30 x 109/L, Absolute neutrophil count (ANC) > 1.0 x 109/L, INR < 3, Total Bilirubin < 4 x institutional UNL, AST or ALT < 6 x institutional ULN.
• Not pregnant
• Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial