Active — Not RecruitingPhase 2

TheraSphere With Durvalumab and Tremelimumab for HCC

United States100 participantsStarted 2023-11-03

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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).

Exclusion criteria

✕. 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.

What they're measuring

Objective Response Rate (ORR)

Timeframe: 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)

Trial details

NCT IDNCT05063565

SponsorBoston Scientific Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-06

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