Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Adenocarcinoma

Carcinoma, Hepatocellular

Liver Diseases

Liver Neoplasms

Gastrointestinal Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

All Drugs and Chemicals

Antineoplastic Agents

Hematinics

Immunomodulating Agents

Durvalumab

Liver Extracts

Tremelimumab

Immunologic Factors

Antineoplastic Agents, Immunological

TheraSphere followed by Tremelimumab plus Durvalumab administered once, then repeated administration of Durvalumab monthly up 18 months.

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

TheraSphere Y-90 glass microsphere therapy

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

Durvalumab (Imfinzi) immunotherapy

Tremelimumab immunotherapy

Patrice Feaster

Maile Krumpschmidt, MD

Shamar Young

Adam Burgoyne

Huat Lim

David Seeh

Aiwu He

Shelley Collins

Qandeel Qandeel Anwar

Beau Toskich

Jesse Molina

Audrey Kam

Aurelie Desgardin

Anjana Pillai

Eric Grubbs

Paul Haste

Jessica Denaud

Nicole Perry

Lingling Du

Connie Dale

Siobhan Flanagan

Tami Perkins

Dan Giardina

Dunbar Sharpe

Nina Beri

Rama Thota

rama Thota

Yann Touchefeu

Thomas Decaens

Frédéric Oberti

Jean Frederic Blanc

Eric Assenat

Frédéric Oberti, MD

Clarisse Rechede

Julien Edeline

Maria Varelo

Andoni Salvatierra

Bruno Sangro

Ana Maria Matilla

Ana Maria Matilla, MD

Joaquina Martinez Galan

Carolina Garcia

Antonio Guerrero

Jose L Lledo

Beau Toskich, MD

Aiwu Ruth He, MD PhD

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.

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.

TheraSphere With Durvalumab and Tremelimumab for HCC

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)

Complete response and partial response evaluated by mRECIST.

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

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

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

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

a. 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

Biocompatibles UK Ltd

Boston Scientific Corporation

Spots Global Cancer Trial Database for tremelimumab immunotherapy