Clinical Trials Logo

Clinical Trial Summary

The goal of this research study is to evaluate the safety and tolerability of tremelimumab and durvalumab with or without Selective Internal Yttrium-90 Radioembolization (SIRT) in participants with resectable hepatocellular carcinoma (HCC) who will undergo liver surgery. The names of the interventions involved in this study are: - Durvalumab (a type of immunotherapy) - Tremelimumab (a type of immunotherapy) - Selective Internal Yttrium-90 Radioembolization (SIRT) (a type of radiation microsphere bead)


Clinical Trial Description

This is a Phase 1, open-label, randomized research study to evaluate the safety and tolerability of tremelimumab and durvalumab with or without Selective Internal Yttrium-90 Radioembolization (SIRT) in participants with resectable hepatocellular carcinoma (HCC) who will undergo liver surgery. Participants will be randomized into one of two treatment groups: Durvalumab + Tremelimumab versus Durvalumab + Tremelimumab + SIRT. Randomization means that a participant is put into a group by chance. Radioembolization is a combination of radiation therapy and a procedure called embolization to treat cancer. SIRT blocks tumor blood supply by injecting radioactive particles into the hepatic artery and delivers internal radiotherapy on the tumor. The U.S. Food and Drug Administration (FDA) has not approved Durvalumab as treatment for HCC but it has been approved for other uses. The U.S. FDA has not approved tremelimumab as a treatment option for HCC. The research study procedures include screening for eligibility, study treatment including evaluations, radiology scans of the liver, blood tests, electrocardiograms, and follow up visits. Participation in this study is expected to last about 18 months with long-term follow up for a maximum of 3 years. It is expected that about 20 people will take part in this research study. AstraZeneca, a pharmaceutical company, is supplying the study drugs, tremelimumab and durvalumab. Sirtex Medical Inc., a medical device company, is supplying the Yttrium-90 resin Microsphere beads. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05701488
Study type Interventional
Source Dana-Farber Cancer Institute
Contact Jiping Wang, MD, PhD
Phone 617-732-8910
Email jwang39@partners.org
Status Recruiting
Phase Phase 1
Start date April 21, 2023
Completion date October 1, 2025

See also
  Status Clinical Trial Phase
Recruiting NCT04209491 - Interest of the Intervention of a Nurse Coordinator in Complex Care Pathway
Completed NCT03963206 - Cabozantinib toLERANCE Study in HepatoCellular Carcinoma (CLERANCE) Phase 4
Completed NCT03268499 - TACE Emulsion Versus Suspension Phase 2
Recruiting NCT05044676 - Immune Cells as a New Biomarker of Response in Patients Treated by Immunotherapy for Advanced Hepatocellular Carcinoma
Recruiting NCT05263830 - Glypican-3 as a Prognostic Factor in Patients With Hepatocellular Carcinoma Treated by Immunotherapy
Recruiting NCT05095519 - Hepatocellular Carcinoma Imaging Using PSMA PET/CT Phase 2
Recruiting NCT05497531 - Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers N/A
Completed NCT05068193 - A Clinical Trial to Compare the Pharmacokinetics and Bioequivalence of "BR2008" With "BR2008-1" in Healthy Volunteers Phase 1
Active, not recruiting NCT03781934 - A Study to Evaluate MIV-818 in Patients With Liver Cancer Manifestations Phase 1/Phase 2
Terminated NCT03655613 - APL-501 or Nivolumab in Combination With APL-101 in Locally Advanced or Metastatic HCC and RCC Phase 1/Phase 2
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT04242199 - Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors Phase 1
Completed NCT04401800 - Preliminary Antitumor Activity, Safety and Tolerability of Tislelizumab in Combination With Lenvatinib for Hepatocellular Carcinoma Phase 2
Withdrawn NCT05418387 - A Social Support Intervention to Improve Treatment Among Hispanic Kidney and Liver Cancer Patients in Arizona N/A
Active, not recruiting NCT04039607 - A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma Phase 3
Terminated NCT03970616 - A Study of Tivozanib in Combination With Durvalumab in Subjects With Advanced Hepatocellular Carcinoma Phase 1/Phase 2
Recruiting NCT03642561 - Evaluation the Treatment Outcome for RFA in Patients With BCLC Stage B HCC in Comparison With TACE Phase 2/Phase 3
Recruiting NCT04118114 - Phase II Study of PRL3-ZUMAB in Advanced Solid Tumors Phase 2
Recruiting NCT06239155 - A Phase I/II Study of AST-3424 in Subjects With Advanced Solid Tumors Phase 1/Phase 2
Completed NCT03222076 - Nivolumab With or Without Ipilimumab in Treating Patients With Resectable Liver Cancer Phase 2