RecruitingHepatocellular Carcinoma
Therasphere® and Systemic Therapy for Patients With Hepatocellular Carcinoma That is High-risk
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
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About this study
The purpose of this research is to compare progression free survival between two available systemic therapies - immunotherapy and tyrosine kinase inhibitors - after Therasphere® (yttrium-90) treatment in adult patients with advanced hepatocellular carcinoma. The immunotherapy consists of a standard-of-care treatment with Atezolizumab and Bevacizumab. Treatment with tyrosine kinase inhibitors consists of standard-of-care Lenvatinib or Cabozantinib.
Sponsor: Northwestern University
You may qualify if…
- ✓ 3.1.1 Patients must have a diagnosis of hepatocellular carcinoma (HCC) confirmed by American Association for Study of Liver Diseases (AASLD) guidelines with a Childs-Pugh score of A or B7 \[Appendix 5\] NOTE: If the patient does not have histological confirmation of disease by biopsy, diagnosis of HCC must be documented with approval by a tumor board or other multidisciplinary conference. Please refer to the appropriate source documents.
- ✓ 3.1.2 Patients must have at least 1 lesion that is measurable using RECIST guidelines. NOTE: A previously irradiated lesion can be considered a target lesion if the lesion is well defined, measurable per RECIST, and has clearly progressed.
- ✓ 3.1.3 Patients may be treatment -naïve or have received any number of prior therapies. NOTE: Prior cancer targeted immunotherapy for any other cancer is contraindicated and not permitted.
- ✓ 3.1.4 Adults ≥18 years old of either gender are eligible.
- ✓ 3.1.5 Patients must exhibit an ECOG performance status of 0, 1, or 2 \[Appendix 1\]
- ✓ 3.1.6 Patients must have adequate organ function prior to registration as determined by: Hemoglobin (HgB) ≥ 8.5 g/dL (without the use of growth factors, transfusion permitted), Absolute Neutrophil Count (ANC) ≥ 50 x 109/L (without use of growth factors \[i.e., IL-11\], transfusion permitted to achieve this value), Prothrombin time (PT)/ International normalized ratio ≤ 2.3 or PT ≤ 6 seconds above control, Calculated creatinine clearance (CrCl) or 24-hour urine CrCl \> 30 mL/min, Serum Bilirubin ≤ 3 times the upper limit of normal (ULN), AST 10X ULN, ALT 10X ULN
- ✓ 3.1.7 Females of childbearing potential (FOCBP), and non-sterilized males who are sexually active must agree to the use of two methods of contraception, with one method being highly effective and the other method being either highly effective or less effective as listed in Appendix 3. They must also refrain from egg and/or sperm cell donation and breastfeeding for 90 days after the final dose of investigational product(s). FOCBP are defined as those who are not surgically sterile (i.e., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause) FOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment. Men who are sexually active with FOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment.
- ✓ 3.1.8 FOCBP must have a negative pregnancy test (Serum or urine pregnancy test per site investigator discretion) prior to registration.
You may not qualify if…
- ✕ 3.2.1 Patients who are concurrently enrolled in another clinical study unless it is an observational (noninterventional) clinical study or the follow-up period of an interventional study.
- ✕ 3.2.2 Patients who are receiving any other investigational agents within 28 days of registration.
- ✕ 3.2.3 Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to Y-90, PD-1 \&PD-L1 antagonists and TKI's. Note: Patients must not have a history of severe allergic reactions (i.e., Grade 4 allergy, anaphylactic reaction from which the subject did not recover within 6 hours of initiation of supportive care) to any unknown allergens or any components of the systemic therapy
- ✕ 3.2.4 Patients must not have had prior treatment any PDL1 or PD-1 antagonists.
- ✕ 3.2.5 Patients who have known additional malignancy that progressed or required treatment within the last 3 years. Note: Exceptions include adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for at least three years.
- ✕ 3.2. 6 Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including chronic prolonged systemic corticosteroids (defined as corticosteroid use of duration one month or greater), should be excluded.
- ✕ 3.2.7 Patients with renal failure currently requiring dialysis of any kind.
- ✕ 3.2.8 Patients with untreated central nervous system (CNS) metastatic disease (including spinal cord and leptomeningeal disease) are excluded. Note: Subjects with previously treated CNS metastases that are radiographically and neurologically stable for at least 6 weeks and do not require corticosteroids (of any dose) for symptomatic management are permitted to enroll.
Where it's recruiting
Illinois
Chicago · DeKalb · Geneva · Grayslake …
Source: ClinicalTrials.gov · NCT05620771 · last updated 2026-05-26