Efficacy Evaluation of TheraSphere in Patients With Inoperable Liver Cancer

Overview

About this study

The safety and effectiveness of TheraSphere will be evaluated in patients with unresectable hepatocellular carcinoma in whom treatment with standard-of-care sorafenib is planned. All patients receive the standard-of-care sorafenib with or without the addition of TheraSphere.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Study closed to enrollment

Inclusion Criteria:

  • Signed informed consent prior to any study-related evaluation
  • Male or female patients over 18 years of age
  • Unresectable HCC confirmed by histology or by non-invasive AASLD criteria
  • Measurable disease defined as at least one uni-dimensional measurable lesion by CT or MRI according to RECIST 1.1
  • Must not have a history of organ allograft
  • Child Pugh score ≤ 7 points
  • ECOG Performance Status score of ≤ 1
  • Life expectancy of 12 weeks or more
  • Eligible to receive standard-of-care sorafenib
  • Platelet count of > 50 x 10⁹ or > 50% prothrombin activity
  • Hemoglobin ≥ 85 mg/mL
  • Bilirubin ≤ 2 mg/dL
  • ALT and AST ≤ 5 X upper limit of normal
  • Amylase and lipase 1,5 X upper limit of normal
  • Serum creatinine ≤ 1.5 X upper limit of normal
  • INR < 2.0

Exclusion Criteria:

  • Main portal vein thrombosis
  • Eligible for curative treatment (ablation or transplantation)
  • Eligible for transarterial chemoembolization (TACE)
  • History of previous or concurrent cancer other than HCC unless treated curatively 5 or more years prior to entry
  • Confirmed presence of extra-hepatic disease except lung nodules and mesenteric or portal lymph nodes ≤ 2.0 cm each
  • Risk of hepatic or renal failure
  • Tumor replacement > 70% of total liver volume based on visual estimation by investigator OR tumor replacement >50% of total liver volume in the presence of albumin <3 mg/dL
  • History of severe allergy or intolerance to contrast agents, narcotics sedatives or atropine that cannot be managed medically
  • Contraindications to angiography and selective visceral catheterization
  • Known contraindications to sorafenib including allergic reaction, pill-swallowing difficulty, uncontrolled hypertension or history of cardiac disease, significant GI bleed within 30 days, metastatic brain disease, renal failure requiring dialysis
  • Must not be taking any of the following: Rifampicin, St. John's Wort, phenytoin, carbamazepine, phenobarbital, dexamethasone
  • Must not be taking any other systemic anticancer agent (docetaxel, doxorubicin, irinotecan)
  • Must not be taking any substrate agents for CYP 2B6 (bupropion, cyclophosphamide, efavirenz, ifosfamide, methadone, paclitaxel, amodiaquine, repaglinide)
  • Must not be taking any UGT 1A1 and UGT 1A9 substrates (e.g. irinotecan)
  • Must not be taking P-Gp substrates (e.g. Digoxin)
  • Prior liver resection < 6 months prior to randomization
  • Prior external beam radiation treatment to the liver or abdomen
  • Prior yttrium-90 microsphere treatment to the liver
  • Prior treatment with transarterial chemoembolization (TACE) or bland embolization < 6 months prior to randomization and must have been applied to a treatment field and/or lobe not targeted for treatment under this protocol
  • Anti-cancer therapy or any treatment with an investigational agent within 30 days prior to randomization
  • Adverse effects due to prior therapy unresolved at randomization
  • Prior systemic treatment for the treatment of HCC
    • Limited sorafenib exposure allowed
  • History of pulmonary compromise, such as chronic obstructive pulmonary disease
  • Intervention for, or compromise of, the Ampulla of Vater
  • Clinically evident ascites (trace ascites on imaging is acceptable)
  • Pregnancy or breast feeding
  • Women of child-bearing potential must have a negative serum pregnancy test within 14 days prior to randomization
  • Disease or condition that would preclude safe use of TheraSphere, including concurrent dialysis treatment, or unresolved serious infections

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Lewis Roberts, M.B., Ch.B., Ph.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
.

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