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Yttrium-90 Microsphere Radioembolization for Enabling Resection of Liver Cancer
Trial Status: active
This clinical trial studies the most effective dose of yttrium-90 microsphere radioembolization to increase liver volume and make patients with liver cancer eligible for liver surgery (resection). Yttrium-90 microsphere radioembolization uses radioactive beads (microspheres), which are tiny glass particles that are loaded with radiation. The beads are injected into an artery of the liver that supplies blood to the tumor(s). The beads flow to the tumor(s) and become trapped inside. The beads release the yttrium-90 radiation inside the tumor(s). This allows a large local dose of radiation to be delivered to the tumor(s) with less risk of side effects from radiation to other parts of the body or to healthy liver tissue. Patients with liver cancer may be liver resection candidates if they have a large enough liver. Yttrium-90 radioembolization may also increase the liver’s size and volume to enable the patient to have a liver resection to remove the liver cancer disease. This research may help determine the best yttrium-90 dose for future patients who need a larger liver to have a liver resection.
Inclusion Criteria
Patients must have been diagnosed with a hepatic malignancy confirmed by histology or must meet one of the following American Association for the Study of Liver Diseases (AASLD) guidelines for the diagnosis of HCC:
* Alpha-fetoprotein (AFP) > 200 and radiological evidence (arterial hypervascularity) of lesion > 2 cm does not require biopsy
* Two imaging modalities (triphasic computed tomography [CT], magnetic resonance imaging [MRI], ultrasound, angiography) demonstrating arterial hypervascularity in the background of cirrhosis does not require biopsy
* One imaging modality with a lesion with arterial hypervascularity with wash out in early or delayed venous phase, does not require a biopsy
Child-Pugh stage A
Future Liver Remnant (FLR) of < 40%
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Bilirubin =< 3.0 mg/dl- Treatment may proceed if the bilirubin is elevated if the tumor may be isolated from a vascular standpoint
Creatinine =< 2.0 mg/dl
Absolute neutrophil count (ANC) >= 1.5 K/uL
Platelets > 25 K/uL
Patient is willing participate in this study and has signed consent the consent
For Group 2 patients only:
* Patients planned 90Y dose and embolic load is found to fall within the optimal dose and embolic load size from data from Group 1 patients
Exclusion Criteria
Patient must not be pregnant, plan to get pregnant or breast-feeding.
* The effects of Y90, MRI and contrast agents on the developing human fetus are unknown. For this reason and because sedative agents (fentanyl and versed) used in this trial are not safe in pregnant women, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a female patient become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and for the duration of study participation
* NOTE: A female of childbearing potential (FOCBP) is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
** Has not undergone a hysterectomy or bilateral oophorectomy
** Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for > 12 months)
For Patients in Group 2 only:
* Patients who have contraindications to MRI:
** Patients that are claustrophobic and haven’t been able to tolerate an MRI in the past. (Patients with mild claustrophobia are eligible and have the option to take 1 mg oral lorazepam prior to the MRI, if needed)
** Allergy to gadolinium-containing contrast media
** Patients with a pacemaker, metallic clip, aneurysm clips, shrapnel fragments, etc.
** Patients with an estimated glomerular filtration rate (eGFR) < 30 mL/min/m^2
Must not have any significant life-threatening extra-hepatic disease or life-threatening secondary malignancies, including patients who are on dialysis, have unresolved diarrhea, have serious unresolved infections including patients who are known to be human immunodeficiency virus (HIV) positive or have acute hepatitis B virus (HBV) or hepatitis C virus (HCV)
Must not have any contraindications to angiography and selective visceral catheterization such as bleeding diathesis or coagulopathy that is not correctable by usual therapy of hemostatic agents (e.g. closure device)
Must not have any co-morbid disease or condition that would place the patient at undue risk and preclude safe use of TheraSphere treatment, in the investigator’s judgment
History of severe peripheral allergy or intolerance to contrast agents, narcotics, sedatives or atropine that cannot be managed medically
Additional locations may be listed on ClinicalTrials.gov for NCT04390724.
I. Measure the distribution of 90Y glass microspheres throughout the tumor and non-tumor hepatic parenchyma, as assessed by same day post-radioembolization study-specific non-fludeoxyglucose F 18 (FDG) positron emission tomography (PET)/computed tomography (CT) scan. (Group 1)
II. Assess the association of circulating and imaging biomarkers on future liver remnant hypertrophy. (Group 2)
III. Assess progression-free survival between subjects with hepatocellular carcinoma (HCC) who underwent resection following yttrium Y-90 (Y-90) radioembolization and those who presented with an adequate future liver remnant for resection (i.e. who were not treated pre-surgically). (Group 2)
OUTLINE: Patients are assigned to 1 of 2 groups.
GROUP 1: Patients receive Y-90 microsphere radioembolization per institutional guidelines and practices.
GROUP 2: Patients receive optimal Y-90 microsphere radioembolization dose and sphere load determined from Group 1 results. Patients who show adequate future liver remnant (FLR) after radioembolization undergo surgery or transplantation per standard of care.
After completion of study treatment, patients are followed up every 3 months for 1 year post-Y-90 microsphere radioembolization, then annually for 4 years.
