Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE2
100 participants
INTERVENTIONAL
2023-11-03
2027-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
TheraSphere followed by Durvalumab and Tremelimumab
TheraSphere followed by Tremelimumab plus Durvalumab administered once, then repeated administration of Durvalumab monthly up 18 months.
TheraSphere Y-90 glass microsphere therapy
TheraSphere Y-90 glass microsphere therapy administered through the hepatic artery at index procedure.
Durvalumab (Imfinzi) immunotherapy
1500 mg, every 4 weeks that continues for a maximum duration of 18 months or until confirmed progression (by site assessment), unacceptable toxicity, study withdrawal, or study early termination by the sponsor. Treatment beyond confirmed radiographic progression is permitted per patient consent if the following criteria are met:
* Absence of clinical symptoms or signs indicating clinically significant disease progression
* No decline in performance status
* Absence of rapid disease progression or threat to vital organs or critical anatomical sites (i.e. new CNS metastasis, respiratory failure due to tumor compression, spinal cord compression) requiring urgent alternative medical intervention
* No other treatment discontinuation criteria are met
Tremelimumab immunotherapy
300 mg, single administration
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TheraSphere Y-90 glass microsphere therapy
TheraSphere Y-90 glass microsphere therapy administered through the hepatic artery at index procedure.
Durvalumab (Imfinzi) immunotherapy
1500 mg, every 4 weeks that continues for a maximum duration of 18 months or until confirmed progression (by site assessment), unacceptable toxicity, study withdrawal, or study early termination by the sponsor. Treatment beyond confirmed radiographic progression is permitted per patient consent if the following criteria are met:
* Absence of clinical symptoms or signs indicating clinically significant disease progression
* No decline in performance status
* Absence of rapid disease progression or threat to vital organs or critical anatomical sites (i.e. new CNS metastasis, respiratory failure due to tumor compression, spinal cord compression) requiring urgent alternative medical intervention
* No other treatment discontinuation criteria are met
Tremelimumab immunotherapy
300 mg, single administration
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. 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.
3. Life expectancy ≥6 months.
4. HCC, diagnosed by radiographic imaging or histology.
5. Patient not a candidate for liver resection, thermal ablation, or transplantation at the time of study entry.
6. ECOG 0 or 1
7. Measurable disease by mRECIST criteria (e.g. ≥10mm of enhancement).
8. Tumor volume ≤35% of whole liver volume (determined by imaging).
9. 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.
10. Dosimetry criteria for tumor(s) and normal tissue can be determined.
11. Patients with previous liver resection or ablation ≥6 months from end of previous treatment to TheraSphere administration.
12. Previous transarterial chemoembolization (TACE) is permitted if:
1. Previous TACE performed ≥8 months before TheraSphere administration and
2. Result of previous TACE was CR and
3. Current tumor is not a recurrence of previously treated lesion
13. Patients with portal vein thrombosis (PVT) Vp0, Vp1, or Vp2.
14. Patients with HBV or HCV infection are to have documented virology status of hepatitis as confirmed by HBV and HCV serology test:
1. 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
2. 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
15. 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
16. Negative serum pregnancy test in females of childbearing potential.
17. Adequate contraception for the patient and his/her sexual partner.
18. Adequate renal and marrow function as defined below:
1. Hemoglobin (hgB) ≥9.0 g/dL
2. Absolute neutrophil count (ANC) ≥1.5 x 109/L
3. Platelet count ≥75 x 109/L
4. Measured or calculated creatinine clearance ≥45 mL/min as determined by Cockcroft-Gault (using actual body weight)
19. Absolute lymphocyte count ≥0.5 X 109/L
20. Adequate liver function, as defined by
1. Child-Pugh A
2. Albumin-bilirubin (ALBI) score 1 or 2 with upper limit for ALBI score ≤ -2. Patients with confirmed Gilbert's syndrome may not have an evaluable bilirubin value; therefore, ALBI score should not be considered for such patients. Patients with Gilbert's syndrome will be eligible with any bilirubin value, as long as Albumin level is ≥ 34 g/L.
3. AST and ALT \<3 x ULN.
21. Body weight \>30 kg and BMI ≥18 kg/m2.
Exclusion Criteria
2. 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.
3. 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.
4. 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.
5. Vp3, Vp4, hepatic vein invasion, or inferior vena cava (IVC) invasion
6. Extrahepatic metastases (patients with extrahepatic spread \[EHS\]):
1. EHS is any extrahepatic lesion that, according to clinical symptoms, histology, or imaging data, is highly suspicious of being metastases.
2. 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.
3. Extrahepatic non-target non-measurable lesions (\<1 cm per RECIST 1.1) are acceptable if considered not suspicious by the investigator.
7. Any previous systemic HCC treatment
8. 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.
9. Previous liver radiation (external beam radiation therapy (EBRT) or peptide receptor radionuclide therapy (PRRT)).
10. 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
11. Hepatic encephalopathy present at study entry and/or episodes of encephalopathy (Grade ≥ 2) within 6 months prior to study inclusion.
12. HCC with infiltrative disease that is not evaluable by mRECIST.
13. 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)).
14. Medical history of radiation pneumonitis or recent pneumonitis, regardless of causality
15. History of any organ allograft, including bone marrow allo and autograft.
16. 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).
17. 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:
1. Patients with vitiligo or alopecia
2. Patients with hypothyroidism (e.g. following Hashimoto's syndrome) stable on hormone replacement therapy
3. Any chronic skin condition that does not require systemic therapy.
4. Patients without active disease in the last 5 years may be included but only after consultation with the Sponsor Study physician.
5. Patients with celiac disease controlled by diet alone.
18. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:
1. Intranasal, inhaled, topical steroids, or local steroid injections (e.g. intra-articular injection)
2. Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent.
3. Steroids as premedication for hypersensitivity reactions (e.g. CT scan premedication).
19. History of gastrointestinal bleeding within 42 days prior to study inclusion, active GI bleeding and any bleeding diathesis or coagulopathy that is not correctable by usual therapy or hemostatic agents (e.g. closure device). Patients with known varices that have not bled or which have been clinically addressed can enter the study. No endoscopic exploration is required before study inclusion.
20. Presence of biliary stent or sphincterotomy within one year prior to study inclusion.
21. History of malignancy, other than HCC, within three years, except the condition is one of the following:
1. Adequately treated carcinoma in situ of the cervix, early squamous cell carcinoma or basal cell carcinoma of the skin, localized prostate cancer, breast ductal carcinoma in situ, or low-grade endometrial carcinoma with no myometrial invasion
2. Localized prostate cancer under active surveillance.
3. Other cancer when there is a negligible risk of recurrence or progression or death (5-year OS rate \> 90%).
22. Major surgical procedure (as defined by the Investigator) within 42 days prior to study inclusion.
23. A history of severe allergy or intolerance to contrast agents, narcotics, sedatives or atropine that cannot be managed medically.
24. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients that cannot be managed medically.
25. Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice), HBV and HVC co-infection, HBV and Hep D co-infection, human immunodeficiency virus (HIV 1/2 antibodies) plus HCV or HBV co-infection.
26. Receipt of live attenuated vaccine within 30 days prior to the first dose of durvalumab and/or tremelimumab. Note: patients, if enrolled, should not receive live vaccine whilst receiving durvalumab and/or tremelimumab and up to 30 days after the last dose of durvalumab and/or tremelimumab.
27. Female patients who are pregnant or breastfeeding and who do not want to stop breastfeeding. Male or female patients of reproductive potential who are not willing to employ any effective birth control method from screening and for at least 90 days after TheraSphere administration, 90 days after the last dose of durvalumab, and 6 months after the last dose of tremelimumab.
28. Unstable chronic disease or evidence of any disease or condition that would place the patient at undue risk and preclude safe use of TheraSphere, durvalumab and tremelimumab treatment as deemed by the site principal investigator.
29. Patients who are not able to follow the TheraSphere, durvalumab or tremelimumab treatment requirements.
For France Patients Only
30. Persons deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric care under articles L. 3212-1 and L. 3213-1 who are not covered by the provisions of Article L. 1121-8 and persons admitted to a health or social establishment for purposes other than research, including:
1. Pregnant, parturient, breast-feeding women (see also inclusion criterion 16 and exclusion criterion 27)
2. Minors (see also inclusion criterion 1)
4. Persons admitted to a health or social establishment for purposes other than research
5. Person of full age under curatorship
6. Adult subject to a mandate for future protection, a family authorization, or a guardianship measure
7. Person not affiliated or not beneficiary of a social security scheme
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Biocompatibles UK Ltd
INDUSTRY
Boston Scientific Corporation
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Beau Toskich, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Aiwu Ruth He, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Georgetown University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Azienda Sanitaria Universitaria Integrata Friuli Centrale (ASU FC)
Udine, , Italy
Hospital Clinic de Barcelona
Barcelona, Catalonia, Spain
Clinica Universidad de Navarra
Pamplona, Navarre, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
Hospital Gregorio Maranon
Madrid, , Spain
Hospital Universitario Virgen de las Nieves
Madrid, , Spain
Hospital. Ramon Y Cajal
Madrid, , Spain
Hospital Universitari
Valencia, , Spain
Clinico de Valladolid
Valladolid, , Spain
University Hospital of Bern
Bern, , Switzerland
University Hospital Geneva (HUG)
Geneva, , Switzerland
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
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Boston Scientific Website ROWAN Clinical Trial Overview
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
S2472
Identifier Type: -
Identifier Source: org_study_id