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Hepatocellular CarcinomaPhase 2ROWANNCT05063565

TheraSphere With Durvalumab and Tremelimumab for HCC

A Phase 2 study testing TheraSphere Y-90 glass microsphere therapy, Durvalumab (Imfinzi) immunotherapy and Tremelimumab immunotherapy in people with Hepatocellular Carcinoma, run by Boston Scientific Corporation at 35 sites in 5 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
TheraSphere Y-90 glass microsphere therapy, Durvalumab (Imfinzi) immunotherapy and Tremelimumab immunotherapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
35 sitesin 5 countries
Study dates
3 Nov 2023to Jun 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • Platelet count ≥75 x 109/L
  • Measured or calculated creatinine clearance ≥45 mL/min as determined by Cockcroft-Gault (using actual body weight)
  • Absolute lymphocyte count ≥0.5 X 109/L
  • Adequate liver function, as defined by
  • Child-Pugh A
  • 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.
  • AST and ALT <3 x ULN.
  • Body weight >30 kg and BMI ≥18 kg/m2.

Who cannot join

  • 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]):
Show all 52Show fewer
  • 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.
  • Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:
  • Intranasal, inhaled, topical steroids, or local steroid injections (e.g. intra-articular injection)
  • Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent.
  • Steroids as premedication for hypersensitivity reactions (e.g. CT scan premedication).
  • 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.
  • Presence of biliary stent or sphincterotomy within one year prior to study inclusion.
  • History of malignancy, other than HCC, within three years, except the condition is one of the following:
  • 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
  • Localized prostate cancer under active surveillance.
  • Other cancer when there is a negligible risk of recurrence or progression or death (5-year OS rate > 90%).
  • Major surgical procedure (as defined by the Investigator) within 42 days prior to study inclusion.
  • A history of severe allergy or intolerance to contrast agents, narcotics, sedatives or atropine that cannot be managed medically.
  • Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients that cannot be managed medically.
  • 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.
  • 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.
  • 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.
  • 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.
  • Patients who are not able to follow the TheraSphere, durvalumab or tremelimumab treatment requirements.
  • For France Patients Only
  • 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:
  • Pregnant, parturient, breast-feeding women (see also inclusion criterion 16 and exclusion criterion 27)
  • Minors (see also inclusion criterion 1)
  • Persons receiving psychiatric treatment (see also exclusion criteria 28)
  • Persons admitted to a health or social establishment for purposes other than research
  • Person of full age under curatorship
  • Adult subject to a mandate for future protection, a family authorization, or a guardianship measure
  • Person not affiliated or not beneficiary of a social security scheme

Trial locations and contacts

35 sites in 5 countries.

35 sites in 5 countries

United States12 sites

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Chicago Hospital

    Chicago, Illinois, 60637

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Columbia University Irving Medical Center

    New York, New York, 10032

  • Intermountain Health

    Salt Lake City, Utah, 84157

  • University of California San Diego

    San Diego, California, 92093

  • University of California San Francisco

    San Francisco, California, 94143

  • Washington University (Barnes-Jewish Hospital)

    St Louis, Missouri, 63101

  • Georgetown University

    Washington D.C., District of Columbia, 20007

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

Other trials in United States

France10 sites

  • CHU de Bordeaux - Hôpital Haut-Lévêque

    Clermont-Ferrand

  • Hôpital Beaujon

    Clichy, Hauts De Seine, 92110

  • Chu Henri Mondor

    Créteil, 94010

  • CHU Grenoble

    Grenoble, Isere, 38043

  • Chru De Lille

    Lille, 59037

  • CHU Montpellier

    Montpellier, 34295

  • CHU Angers - Hôpital Hôtel Dieu

    Nantes, 49033

  • CHU Nantes

    Rennes, Cedex, 35042

  • CRLCC Eugene Marquis

    Rennes

  • Hopital Paul Brousse

    Villejuif, 94800

Other trials in France

Spain8 sites

  • Hospital Clinic de Barcelona

    Barcelona, Catalonia, 08036

  • Hospital Gregorio Maranon

    Madrid

  • Hospital Universitario Virgen de las Nieves

    Madrid

  • Hospital. Ramon Y Cajal

    Madrid

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33006

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008

  • Hospital Universitari

    Valencia, 46026

  • Clinico de Valladolid

    Valladolid, 47012

Other trials in Spain

Italy3 sites

  • National Cancer Institute of Milan, Italy

    Milan, 20133

  • IRCCS - Regina Elena Cancer Institute

    Roma

  • Azienda Sanitaria Universitaria Integrata Friuli Centrale (ASU FC)

    Udine

Other trials in Italy

Switzerland2 sites

  • University Hospital of Bern

    Bern, 3010

  • University Hospital Geneva (HUG)

    Geneva, 1211

Other trials in Switzerland

About this study

Official title: An Open-Label, Prospective, Multi-Center Clinical Trial to Evaluate the Efficacy and Safety of TheraSphere™ Followed by Durvalumab (Imfinzi®) With Tremelimumab (Imjudo®) for Hepatocellular Carcinoma (HCC)

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.

Read the detailed description

A global open-label, prospective, multi-center Phase II trial designed to assess the safety and efficacy of TheraSphere administered before initiation of Durvalumab with Tremelimumab in HCC patients who are not a candidate for resection, thermal ablation or liver transplant at the time of study entry.

Being tested
TheraSphere Y-90 glass microsphere therapy, Durvalumab (Imfinzi) immunotherapy, Tremelimumab immunotherapy
Keywords
Carcinoma, Carcinoma, Hepatocellular, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Neoplasms, Adenocarcinoma, Liver Neoplasms, Digestive System Neoplasms, Neoplasms by Site, Digestive System Diseases, Liver Diseases
Medical subject headings
Carcinoma, Hepatocellular, Carcinoma, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Neoplasms, Adenocarcinoma, Liver Neoplasms, Digestive System Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TheraSphere Y-90 glass microsphere therapyDevice

    TheraSphere Y-90 glass microsphere therapy administered through the hepatic artery at index procedure.

  • Durvalumab (Imfinzi) immunotherapyDrug

    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 immunotherapyDrug

    300 mg, single administration

Study groups in NCT05063565
Study groupRoleWhat they receive
TheraSphere followed by Durvalumab and TremelimumabExperimentalTheraSphere followed by Tremelimumab plus Durvalumab administered once, then repeated administration of Durvalumab monthly up 18 months.
Receives: Device: TheraSphere Y-90 glass microsphere therapy; Drug: Durvalumab (Imfinzi) immunotherapy; Drug: Tremelimumab immunotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    Complete response and partial response evaluated by mRECIST.

    Measured: Start of Treatment (Day 1) up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (18 months after the last patient is treated)

Secondary outcomes (36)

  1. Number of immune mediated AEs and SAEs.

    Measured: Treatment Day 1 up to participant's death, opposition to data collection, lost to follow-up, or study termination (18 months after the last patient is treated).

  2. Number of patients whose durvalumab and/or tremelimumab treatment was temporarily halted, postponed or permanently discontinued due to an AE.

    Measured: Treatment Day 1 up to participant's death, opposition to data collection, lost to follow-up, or study termination (18 months after the last patient is treated).

  3. Change from baseline in liver function tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT], gamma-glutamyl transpeptidase [GGT], alkaline phosphatase [ALK], bilirubin, albumin).

    Measured: Baseline up to participant's death, opposition to data collection, lost to follow-up, or study termination (18 months after the last patient is treated).

  4. Change from baseline in Child-Pugh score.

    Minimum value is 5 (better) and maximum value is 15 (worse).

    Measured: Baseline up to participant's death, opposition to data collection, lost to follow-up, or study termination (18 months after the last patient is treated).

  5. Change from baseline in Albumin Bilirubin (ALBI) score.

    Minimum value is 1 (better) and maximum value is 3 (worse).

    Measured: Baseline up to participant's death, opposition to data collection, lost to follow-up, or study termination (18 months after the last patient is treated).

  6. Change from baseline in Eastern Cooperative Oncology Group (ECOG) score.

    Minimum value is 0 (better) and maximum value is 5 (worse).

    Measured: Baseline up to participant's death, opposition to data collection, lost to follow-up, or study termination (18 months after the last patient is treated).

  7. ORR according to localized mRECIST and RECIST 1.1.

    Measured: Start of Treatment (Day 1) up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (18 months after the last patient is Treated ).

  8. DoR according to mRECIST, localized mRECIST, and RECIST 1.1.

    Measured: Time of response up to progression, subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (18 months after the last patient is treated).

  9. Disease Control Rate (DCR) according to localized mRECIST, mRECIST, RECIST 1.1.

    Measured: Start of Treatment (Day 1) up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (18 months after the last patient is Treated).

  10. Duration of disease control (DoDC) according to localized mRECIST, mRECIST, RECIST 1.1.

    Measured: Time of disease control up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (18 months after the last patient is treated).

  11. Time to best response (CR or PR) according to localized mRECIST, mRECIST, RECIST 1.1.

    Measured: Start of Treatment (Day 1) up to best response (CR or PR), subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (18 months after the last patient is treated).

  12. Complete response rate (CRR) according to localized mRECIST, mRECIST, RECIST 1.1.

    Measured: Start of Treatment (Day 1) up to complete response, subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (18 months after the last patient is treated).

  13. Duration of complete response (DoCR) according to localized mRECIST, mRECIST, RECIST 1.1.

    Measured: Time of complete response up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (18 months after the last patient is treated).

  14. Hepatic time to progression (hTTP) according to mRECIST, RECIST 1.1.

    Measured: Start of treatment (Day 1) up to hepatic progression, subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (18 months after the last patient is treated).

  15. Time to progression (TTP) according to localized mRECIST, mRECIST, RECIST 1.1.

    Measured: Start of treatment (Day 1) up to progression, subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (18 months after the last patient is treated).

  16. Progression free survival (PFS) according to localized mRECIST, mRECIST, RECIST 1.1; this will include an evaluation of the PFS rate at 6, 12, 18 and 24 months.

    Measured: Start of treatment (Day 1) up to progression, subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (18 months after the last patient is treated).

  17. Hepatic progression free survival (hPFS) by mRECIST, RECIST 1.1.

    Measured: Start of treatment (Day 1) up to hepatic progression, subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (18 months after the last patient is treated).

  18. Overall survival (OS).

    Measured: Start of treatment (Day 1) up to participant's death, opposition to data collection, lost to follow-up, or study termination (18 months after the last patient is treated).

  19. Disease Specific Survival (DSS)

    Measured: Start of treatment (Day 1) up to participant's death, opposition to data collection, lost to follow-up, or study termination (18 months after the last patient is treated).

  20. Proportion of patients receiving subsequent treatment for HCC after study treatment, and type of HCC treatment received.

    Measured: Start of treatment (Day 1) up to participant's death, opposition to data collection, lost to follow-up, or study termination (18 months after the last patient is treated).

  21. Proportion of patients to undergo curative therapy (transplantation or resection).

    Measured: Start of treatment (Day 1) up to participant's death, opposition to data collection, lost to follow-up, or study termination (18 months after the last patient is treated).

  22. Time to subsequent HCC treatment (local or systemic therapy).

    Measured: Start of treatment (Day 1) up to participant's death, opposition to data collection, lost to follow-up, or study termination (18 months after the last patient is treated).

  23. Reason for starting subsequent HCC treatment.

    Measured: Start of treatment (Day 1) up to participant's death, opposition to data collection, lost to follow-up, or study termination (18 months after the last patient is treated).

  24. Alpha fetoprotein (AFP) response.

    Measured: Baseline up to participant's death, opposition to data collection, lost to follow-up, or study termination (18 months after the last patient is treated).

  25. Change from baseline in quality of life (QoL) by FACT-Hep.

    Measured: Baseline up to participant's death, opposition to data collection, lost to follow-up, or study termination (18 months after the last patient is treated).

  26. Change from baseline in QoL by EQ-5D.

    Measured: Baseline up to participant's death, opposition to data collection, lost to follow-up, or study termination (18 months after the last patient is treated).

  27. Pre-treatment volumes and absorbed doses to the following volumes of interest (VOIs) using 99mTc-MAA SPECT/CT imaging and Simplicit90Y dosimetry software will be determined.

    Only tumor ≥3cm of longest diameter should be considered for dosimetry assessment.

    1. Tumoral VOIs i. All Tumor(s) ii. Target lesion(s) according to mRECIST b. Perfused Liver VOI c. Normal liver tissue VOIs i. Perfused normal tissue ii. Whole liver normal tissue

    Measured: Baseline Visit

  28. Post-treatment volumes and absorbed doses to the following volumes of interest (VOIs) using Y-90 PET imaging and Simplicit90Y dosimetry software will be determined.

    Only tumor ≥3cm of longest diameter should be considered for dosimetry assessment.

    1. Tumoral VOIs i. All Tumor(s) ii. Target lesion(s) according to mRECIST b. Perfused Liver VOI c. Normal liver tissue VOIs i. Perfused normal tissue ii. Whole liver normal tissue

    Measured: Treatment Visit

  29. Correlation between tumoral absorbed doses in Gy, determined by 99mTc-MAA SPECT/CT, assessing impact on tumor response and, survival.

    Measured: Start of treatment (Day 1) up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (18 months after the last patient is treated).

  30. Correlation between normal tissue absorbed doses in Gy, determined by 99mTc-MAA SPECT/CT, assessing impact on number of Grade 3 or higher AEs and SAEs.

    Measured: Start of treatment (Day 1) up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (18 months after the last patient is treated).

  31. Correlation between tumoral absorbed doses in Gy, determined by Y-90 PET, assessing impact on tumor response and survival.

    Measured: Start of treatment (Day 1) up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (18 months after the last patient is treated).

  32. Correlation between normal tissue absorbed doses in Gy, determined by Y-90 PET, assessing impact on number of Grade 3 or higher AEs and SAEs.

    Measured: Start of treatment (Day 1) up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (18 months after the last patient is treated).

  33. Correlation between tumoral absorbed doses in Gy determined by 99mTc-MAA SPECT/CT and Y-90 PET.

    Measured: Baseline up to post-treatment imaging visit.

  34. Correlation between normal tissue absorbed doses in Gy determined by 99mTc-MAA SPECT/CT and by Y-90 PET.

    Measured: Baseline up to post-treatment imaging visit.

  35. Determination of dose volume histogram (DVH) for tumoral VOIs and normal liver tissue VOIs, using 99mTc-MAA SPECT/CT and Y-90 PET.

    Measured: Baseline up to post-treatment imaging visit.

  36. Whole liver and remnant liver volumes at baseline and follow-up imaging assessments measured using Simplicit90Y software.

    Measured: Start of Treatment (Day 1) up to participant's death, opposition to data collection, lost to follow-up, or study termination (18 months after the last patient is treated).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2021
  2. Study start3 Nov 2023
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05063565
Sponsor's protocol ID
S2472
Acronym
ROWAN
Status last verified
Oct 2026
First submitted
1 Sep 2021
Last updated
30 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TheraSphere Y-90 glass microsphere therapy, Durvalumab (Imfinzi) immunotherapy and Tremelimumab immunotherapy in people with Hepatocellular Carcinoma, run by Boston Scientific Corporation at 35 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 33 inclusion and 52 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States, France, Spain, Italy, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Start of Treatment (Day 1) up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (18 months after the last patient is treated)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05063565.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.

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