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TheraSphere With Durvalumab and Tremelimumab for HCC

Study acronym: ROWAN
StatusActive, Not Recruiting
PhasePhase 2
Started2023-11-03
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 58 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

2026-08-25
Study Status, Contacts/Locations v57
Study sites36→35
2026-07-30
9 amendments v48-v56
9 re-verifications since 2025-11-26, no change to tracked fields
2025-10-22
Study Status, Oversight, Contacts/Locations v47
Study sitesdetails revised at 2 of 36 sites
2025-09-26
Study Status, Oversight, Contacts/Locations v46
Study sitesdetails revised at 2 of 36 sites
2025-08-21
Recruiting→Active, Not Recruiting Study Status, Oversight, Contacts/Locations v45
Trial statusRecruiting→Active, Not Recruiting
Study sites35→36
Show 37 earlier versions
2025-08-04
Study Status, Oversight, Contacts/Locations v44
Study sitesdetails revised at 1 of 35 sites
2025-06-25
Study Status v43
Re-verified, no change to tracked fields
2025-05-27
Study Status, Contacts/Locations v42
Study sites32→35
2025-04-24
Study Status v41
Re-verified, no change to tracked fields
2025-03-27
Study Status, Contacts/Locations v40
Study sitesdetails revised at 1 of 32 sites
2025-03-03
Study Status, Contacts/Locations v39
Study sites30→32
2025-01-27
Study Status, Contacts/Locations v38
Study sitesdetails revised at 1 of 30 sites
2024-12-23
2 amendments v36-v37
2 re-verifications since 2024-11-26, no change to tracked fields
2024-10-25
Study Status, Contacts/Locations v35
Study sitescontacts updated at 3 of 30 sites
2024-08-23
Study Status, Contacts/Locations v34
Study sites28→30
2024-07-17
Study Status, Contacts/Locations v33
Study sitesdetails revised at 1 of 28 sites
2024-06-26
Study Status, Contacts/Locations v32
Study sites27→28
2024-05-24
Study Status, Contacts/Locations v31
Primary completion date2026-12→2027-06
Study sites25→27
2024-04-22
Study Status, Contacts/Locations v30
Study sites22→25
2024-03-26
Study Status, Contacts/Locations v29
Study sites14→22
2024-02-28
Study Status v28
Re-verified, no change to tracked fields
2024-01-25
Study Status, Contacts/Locations, References v27
Study sites12→14
2023-12-19
Study Status, Contacts/Locations v26
Study sites11→12
2023-11-06
Study Status v25
Re-verified, no change to tracked fields
2023-10-30
Study Status, Eligibility, Contacts/Locations v24
Start date2023-09-20→2023-11-03
Eligibility criteriarevised
[...] al ablation, or transplantation at the time of study entry. ECOFECOG 0 or 1 Measurable disease by mRECIST criteria (e.g. ≥10mm o [...]
Study sitesdetails revised at 2 of 11 sites
2023-09-20
Study Status, Outcome Measures, Contacts/Locations v23
Start date2023-08-31→2023-09-20
Secondary endpointsdetails revised at 1 of 36 entries
Study sitesdetails revised at 3 of 11 sites
2023-08-21
Study Status v22
Primary completion date2027-07→2026-12
Completion date2027-09→2027-06
2023-07-13
Study Status v21
Start date2023-06→2023-08-31
2023-06-29
Suspended→Recruiting Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v20
Trial statusSuspended→Recruiting
Reason stoppedRecruitment has been paused and will resume upon protocol amendment completion.→not stated
Primary completion date2027-03→2027-07
Completion date2027-07→2027-09
Start date2023-05→2023-06
Enrollment target150→100
Study arms2→1
Eligibility criteria+1,260 characters
[...] al ablation, or transplantation at the time of study entry. TreatmentECOF naïve.0 or 1 Measurable disease by mRECIST criteria (e.g. ≥10mm of enhancement). Tumor volume ≤2535% of whole liver volume (determined by imaging). Unilobar tumor Future liver remnant volume (FLRV) ≥30% of whole liver volum [...] 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 [...] [...]
Secondary endpoints36 entries, revised
Number of adverse events (AEs) and serious adverse events (SAEs). ORR according to localized mRECIST, and RECIST 1.1. DoR according to mRECIST, localized mRECIST, and RECIST 1.1. Disease Specific Survival (DSS) Correlation between tumoral absorbed doses in Gy, determined by 99mTc-MAA SPECT/CT, assessing impact on tumor response and, survival and number of Grade 3 or higher AEs and SAEs. Correlation between normal tissue absorbed doses in Gy, determined by 99mTc-MAA SPECT/CT, assessing impact on tumor response, survival and number of Grade 3 or higher AEs and SAEs. Correlation betwe [...] , determined [...]
Primary endpoints2 to 1 entries
Duration of response (DoR)
Study description-33 characters
A global open-label, prospective, multi-center, randomized, Phase II trial with two treatment arms designed to assess the safety and efficacy of TheraSphere a [...] initiation of Durvalumab with Tremelimumab in HCC patients who are not eligiblea candidate for orresection, who have declined treatment with resection and/orthermal ablation or liver transplant at the time of study entry.
Study sitesdetails revised at 11 of 11 sites
Study title-12 characters
TheraSphere With and Without Durvalumab and Tremelimumab for HCC
2023-05-19
Study Status, Contacts/Locations v19
Primary completion date2027-05→2027-03
Completion date2028-05→2027-07
Study sites10→11
2023-04-18
Study Status, Contacts/Locations v18
Study sites9→10
2023-03-16
Study Status v17
Re-verified, no change to tracked fields
2023-02-16
Recruiting→Suspended Study Status, Contacts/Locations v16
Trial statusRecruiting→Suspended
Reason stoppednot stated→Recruitment has been paused and will resume upon protocol amendment completion.
Primary completion date2026-11→2027-05
Completion date2026-11→2028-05
Start date2023-02→2023-05
Study sites8→9
2023-01-17
Study Status v15
Primary completion date2026-10→2026-11
Completion date2026-10→2026-11
Start date2023-01→2023-02
2022-12-13
Study Status, Contacts/Locations v14
Primary completion date2026-09→2026-10
Completion date2026-09→2026-10
Start date2022-12→2023-01
Study sites7→8
2022-11-18
Study Status, Contacts/Locations v13
Primary completion date2026-08→2026-09
Completion date2026-08→2026-09
Start date2022-11→2022-12
Study sites4→7
2022-10-26
Study Status, Contacts/Locations v12
Primary completion date2026-07→2026-08
Completion date2026-07→2026-08
Start date2022-10→2022-11
Study sites3→4
2022-09-27
Study Status, Contacts/Locations v11
Primary completion date2026-06→2026-07
Completion date2026-06→2026-07
Start date2022-09→2022-10
Study sites2→3
2022-08-15
Study Status, Contacts/Locations v10
Primary completion date2026-05→2026-06
Completion date2026-05→2026-06
Start date2022-08→2022-09
Study sites1→2
2022-07-18
Study Status v9
Primary completion date2026-04→2026-05
Completion date2026-04→2026-05
Start date2022-06→2022-08
2022-06-14
Study Status, Contacts/Locations v8
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2026-03→2026-04
Completion date2026-03→2026-04
Study sites0→1
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.
Trial Details
NCT Number NCT05063565
Lead Sponsor Boston Scientific Corporation
Collaborators: Biocompatibles UK Ltd
Conditions Hepatocellular Carcinoma
Enrollment 100 participants
Start Date 2023-11-03
Primary Completion 2027-06 (estimated)
Study Completion 2027-06 (estimated)
Updated on ClinicalTrials.gov 2026-10-01