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Radioactive Agent

TheraSphere + Immunotherapy for Liver Cancer (ROWAN Trial)

Phase 2
Recruiting
Led By Aiwu Ruth He, MD PhD
Research Sponsored by Boston Scientific Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Future liver remnant volume (FLRV) ≥30% of whole liver volume.
HCC, diagnosed by radiographic imaging or histology.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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).
Awards & highlights

ROWAN Trial Summary

This trial is testing a new cancer treatment involving two drugs given after TheraSphere, to see if it is more effective at treating HCC than TheraSphere alone.

Who is the study for?
Adults over 18 with Hepatocellular Carcinoma (HCC) who haven't had systemic HCC treatment, are ineligible for liver resection/ablation/transplantation, and have a tumor volume ≤35% of the liver. They must have adequate organ function, no severe hepatic vein invasion or extrahepatic metastases, and not be in another interventional study.Check my eligibility
What is being tested?
The ROWAN trial is testing TheraSphere Y-90 therapy followed by Durvalumab and Tremelimumab immunotherapies to see how well they control local tumor growth in patients with HCC. The effectiveness will be measured using specific imaging criteria.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system affecting organs, fatigue, blood-related issues like low counts of different types of cells which can increase infection risk, potential kidney problems from contrast agents used during scans.

ROWAN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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At least 30% of my liver is healthy and functioning.
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I have been diagnosed with liver cancer.
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I cannot have surgery, heat treatment, or a liver transplant for my condition.
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I am fully active or can carry out light work.
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I have a blood clot in the portal vein of my liver.
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I have a confirmed hepatitis B or C status from a blood test.
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I am 18 years old or older.

ROWAN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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).
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate (ORR)
Secondary outcome measures
Alpha fetoprotein (AFP) response.
Change from baseline in Albumin Bilirubin (ALBI) score.
Change from baseline in Child-Pugh score.
+33 more

ROWAN Trial Design

1Treatment groups
Experimental Treatment
Group I: TheraSphere followed by Durvalumab and TremelimumabExperimental Treatment3 Interventions
TheraSphere followed by Tremelimumab plus Durvalumab administered once, then repeated administration of Durvalumab monthly up 18 months.

Find a Location

Who is running the clinical trial?

Boston Scientific CorporationLead Sponsor
720 Previous Clinical Trials
932,922 Total Patients Enrolled
3 Trials studying Liver Cancer
474 Patients Enrolled for Liver Cancer
Biocompatibles UK LtdIndustry Sponsor
24 Previous Clinical Trials
2,429 Total Patients Enrolled
2 Trials studying Liver Cancer
95 Patients Enrolled for Liver Cancer
Aiwu Ruth He, MD PhDPrincipal InvestigatorGeorgetown University

Media Library

Liver Cancer Research Study Groups: TheraSphere followed by Durvalumab and Tremelimumab
Liver Cancer Clinical Trial 2023: TheraSphere Y-90 glass microsphere therapy Highlights & Side Effects. Trial Name: NCT05063565 — Phase 2
TheraSphere Y-90 glass microsphere therapy (Radioactive Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05063565 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently vacant spots available to participants in this research study?

"According to clinicaltrials.gov, this experiment is actively seeking patient enrollment and has been since December 1st 2022. The details of the research were last revised on November 18th 2022."

Answered by AI

What potential adverse effects should be expected from Tremelimumab therapy?

"Our team has evaluated Tremelimumab immunotherapy and given it a rating of 2 due to clinical data which implies safety, but not yet efficacy."

Answered by AI

Is this an innovative research project?

"Tremelimumab immunotherapy has seen an unprecedented level of clinical trial involvement since its first study in 2007. Hosted across 58 countries and 1327 different cities, 340 active trials have been conducted by AstraZeneca alone with 123 studies completing their required Phase 2 drug approval stages."

Answered by AI

How many individuals have been admitted to participate in this trial thus far?

"This clinical trial necessitates the recruitment of 150 qualified candidates. Those who meet the inclusion criteria may register at either Indiana University in Indianapolis or University of Minnesota in Minneapolis."

Answered by AI

What conditions does Tremelimumab immunotherapy typically treat?

"Tremelimumab immunotherapy is typically prescribed to treat late stage non-small cell lung cancer that cannot be surgically removed. It can also provide relief for advanced ureter urothelial carcinoma, as well as other conditions not mentioned here."

Answered by AI

Has Tremelimumab immunotherapy been trialed before?

"The first official investigation of tremelimumab immunotherapy was conducted in 2007 by Research Site. Since then, it has been the subject of 123 completed clinical trials and is presently involved in 340 active studies across Indianapolis, Indiana."

Answered by AI

Are there a multitude of locations hosting this research program within the state?

"Currently, the trial is running in 7 locations spanning from Indianapolis to Jacksonville. It may be prudent for potential participants to opt for a location closer to home in order to reduce travel time and expenses."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
TheraSphere With Durvalumab and Tremelimumab for HCC
2023. "TheraSphere With Durvalumab and Tremelimumab for HCC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05063565.
~67 spots leftby Dec 2026
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