TheraSphere With Durvalumab and Tremelimumab for HCC

Running, not enrolling · Phase 2

Conditions studied: Hepatocellular Carcinoma

In brief

The objective of the ROWAN clinical study is to assess the efficacy of local tumor control in HCC patients who receive TheraSphere followed by durvalumab and tremelimumab.

Key facts

Study ID

NCT05063565

Run by

Boston Scientific Corporation

People needed

100

Starts

2023-11-03

Expected to finish

2027-06-01

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must be aged ≥18 years at the time of screening.
• Written informed consent and any locally required authorization (e.g., Health Insurance Portability and accountability Act in the US, European Union (EU) data privacy regulations in the EU) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
• Life expectancy ≥6 months.
• HCC, diagnosed by radiographic imaging or histology.
• Patient not a candidate for liver resection, thermal ablation, or transplantation at the time of study entry.
• ECOG 0 or 1
• Measurable disease by mRECIST criteria (e.g. ≥10mm of enhancement).
• Tumor volume ≤35% of whole liver volume (determined by imaging).
• Future liver remnant volume (FLRV) ≥30% of whole liver volume. FRLV is the volume of liver not planned to be treated with TheraSphere and free of HCC.
• Dosimetry criteria for tumor(s) and normal tissue can be determined.
• Patients with previous liver resection or ablation ≥6 months from end of previous treatment to TheraSphere administration.
• Previous transarterial chemoembolization (TACE) is permitted if:
• Previous TACE performed ≥8 months before TheraSphere administration and
• Result of previous TACE was CR and
• Current tumor is not a recurrence of previously treated lesion
• Patients with portal vein thrombosis (PVT) Vp0, Vp1, or Vp2.
• Patients with HBV or HCV infection are to have documented virology status of hepatitis as confirmed by HBV and HCV serology test:
• Patients with HBV infection: HBV DNA load should be ≤2000 IU/mL obtained within 42 days prior to initiation of study treatment, and Anti-HBV treatment (per local standard of care; e.g., entecavir) for a minimum of 14 days prior to study entry and willingness to continue treatment for the length of the study
• Patients with chronic HCV infection are allowed in the study: for untreated patients, AST/ALT should be ≤3xULN and for treated patients, antiviral treatment (per local standard of care) should be stopped for a minimum of 14 days prior to study entry and AST/ALT should be ≤3xULN
• Patients with Human Immunodeficiency Virus (HIV) infection are eligible, provided the HIV infection is well controlled with no current or previous AIDS-related complications and CD4+ T-cell (CD4+) counts ≥ 350 cells/uL
• Negative serum pregnancy test in females of childbearing potential.
• Adequate contraception for the patient and his/her sexual partner.
• Adequate renal and marrow function as defined below:
• Hemoglobin (hgB) ≥9.0 g/dL
• Absolute neutrophil count (ANC) ≥1.5 x 109/L

You may not qualify if…

• Any contraindication to angiography or selective visceral catheterization.
• Cone Beam CT (CBCT) or Technetium-99m macroaggregated Albumin (99mTc-MAA) hepatic arterial perfusion scintigraphy shows any deposition to the gastrointestinal tract that may not be corrected by angiographic techniques.
• 99mTc-MAA hepatic arterial perfusion scintigraphy shows poor tumor and/or portal vein thrombosis (PVT) targeting that would lead to a dose that does not meet the liver dosing criteria.
• Shunting of blood to the lungs that could result in delivery of >30 Gy to the lungs in a single treatment or >50 Gy cumulative dose to the lungs in case of multiple TheraSphere treatments, as seen on 99mTc-MAA hepatic arterial perfusion scintigraphy.
• Vp3, Vp4, hepatic vein invasion, or inferior vena cava (IVC) invasion
• Extrahepatic metastases (patients with extrahepatic spread [EHS]):
• EHS is any extrahepatic lesion that, according to clinical symptoms, histology, or imaging data, is highly suspicious of being metastases.
• For patients with bone pain/neurological symptoms (deficit, seizure or else) at baseline and suspected of metastases at screening, a bone scan/brain MRI is recommended prior to study entry.
• Extrahepatic non-target non-measurable lesions (<1 cm per RECIST 1.1) are acceptable if considered not suspicious by the investigator.
• Any previous systemic HCC treatment
• Prior exposure to immune mediated therapy for other disease, such as other anti-PD- 1, anti-PDL-1, anti-PDL-2, anti-CTLA-4, antibodies, etc.
• Previous liver radiation (external beam radiation therapy (EBRT) or peptide receptor radionuclide therapy (PRRT)).
• Concurrent treatment for HCC or treatment in the last 4 weeks in another clinical study, unless it is an observational study (non-interventional) or during a non-interventional follow-up stage of an interventional study, or prior inclusion in this study
• Hepatic encephalopathy present at study entry and/or episodes of encephalopathy (Grade ≥ 2) within 6 months prior to study inclusion.
• HCC with infiltrative disease that is not evaluable by mRECIST.
• Pulmonary insufficiency (defined by an arterial oxygen pressure (PaO2) of <60 mmHg, or oxygen saturation (SaO2) of <90% (Roussos \& Koutsoukou, 2003) or clinically evident chronic obstructive pulmonary disease (COPD)).
• Medical history of radiation pneumonitis or recent pneumonitis, regardless of causality
• History of any organ allograft, including bone marrow allo and autograft.
• History of active primary/acquired immunodeficiency, that makes patients unsuitable for additional immunotherapy in this study (per investigator and as detailed in exclusion criterion #18).
• Active or prior documented autoimmune or inflammatory disorders (including but not limited to, inflammatory bowel disease [e.g. ulcerative colitis or Crohn's disease], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion:
• Patients with vitiligo or alopecia
• Patients with hypothyroidism (e.g. following Hashimoto's syndrome) stable on hormone replacement therapy
• Any chronic skin condition that does not require systemic therapy.
• Patients without active disease in the last 5 years may be included but only after consultation with the Sponsor Study physician.
• Patients with celiac disease controlled by diet alone.

Where it is running

• University of Arizona- Banner Health — Tucson, Arizona, United States
• University of California San Diego — San Diego, California, United States
• University of California San Francisco — San Francisco, California, United States
• Georgetown University — Washington D.C., District of Columbia, United States
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Mayo Clinic — Jacksonville, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Chicago Hospital — Chicago, Illinois, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Washington University (Barnes-Jewish Hospital) — St Louis, Missouri, United States
• Columbia University Irving Medical Center — New York, New York, United States
• Intermountain Health — Salt Lake City, Utah, United States
• CHU Nantes — Rennes, Cedex, France
• Hôpital Beaujon — Clichy, Hauts De Seine, France
• CHU Grenoble — Grenoble, Isere, France
• CHU de Bordeaux - Hôpital Haut-Lévêque — Clermont-Ferrand, France
• Chu Henri Mondor — Créteil, France
• Chru De Lille — Lille, France
• CHU Montpellier — Montpellier, France
• CHU Angers - Hôpital Hôtel Dieu — Nantes, France
• CRLCC Eugene Marquis — Rennes, France
• Hopital Paul Brousse — Villejuif, France
• National Cancer Institute of Milan, Italy — Milan, Italy
• IRCCS - Regina Elena Cancer Institute — Roma, Italy

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.