NCT05701488

SIRT With Tremelimumab and Durvalumab for Resectable HCC

Recruiting now Phase 1 Last updated 2 September 2025

What this trial tests

Phase 1 trial testing Durvalumab in Resectable Hepatocellular Carcinoma in 20 participants. Currently enrolling.

Timeline

21 April 2023

Primary endpoint
1 October 2026

1 October 2026

Quick facts

Lead sponsor	Jiping Wang, MD, PhD
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	21 April 2023
Primary completion	1 October 2026
Estimated completion	1 October 2026
Sites	3 locations across United States

Drugs / interventions tested

• Durvalumab — full drug profile →
• Tremelimumab (TREMELIMUMAB) — full drug profile →
• SIRT

Conditions studied

• Resectable Hepatocellular Carcinoma — all drugs for Resectable Hepatocellular Carcinoma →
• Hepatocellular Carcinoma — all drugs for Hepatocellular Carcinoma →
• Hepatocellular Cancer — all drugs for Hepatocellular Cancer →

Sponsor

Jiping Wang, MD, PhD

Who can join

18 and older, any sex, with Resectable Hepatocellular Carcinoma or Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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)

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Management of Hepatocellular Carcinoma in 2024: The Multidisciplinary Paradigm in an Evolving Treatment Landscape.
   Kinsey E, Lee HM. · · 2024 · cited 68× · PMID 38339417 · DOI 10.3390/cancers16030666
2. Advances in radiotherapy and immunity in hepatocellular carcinoma.
   Yang Y, Xiong L, Li M, Jiang P, et al · · 2023 · cited 37× · PMID 37542324 · DOI 10.1186/s12967-023-04386-y
3. Safety and Efficacy of Concurrent Atezolizumab/Bevacizumab or Nivolumab Combination Therapy with Yttrium-90 Radioembolization of Advanced Unresectable Hepatocellular Carcinoma.
   Villalobos A, Dabbous HH, Little O, Gbolahan OB, et al · · 2023 · cited 14× · PMID 38132368 · DOI 10.3390/curroncol30120734
4. Yttrium-90 Radioembolization Dosimetry: Dose Considerations, Optimization, and Tips.
   Villalobos A, Pisanie JLD, Gandhi RT, Kokabi N. · · 2024 · cited 6× · PMID 38495257 · DOI 10.1055/s-0044-1779715
5. Combined radiotherapy and immune checkpoint inhibition for the treatment of advanced hepatocellular carcinoma.
   Shannon AH, Manne A, Diaz Pardo DA, Pawlik TM. · · 2023 · cited 5× · PMID 37554167 · DOI 10.3389/fonc.2023.1193762
6. Selective internal radiation therapy across Barcelona Clinic Liver Cancer (BCLC) stages of hepatocellular carcinoma: literature review.
   Vigneron P, Franzè MS, Chalaye J, Tacher V, et al · · 2024 · cited 4× · PMID 39669087 · DOI 10.21037/hbsn-23-504
7. Evidence to Date: Clinical Utility of Tremelimumab in the Treatment of Unresectable Hepatocellular Carcinoma.
   Ahmed Z, Lee SS, Victor DW, Kodali S. · · 2023 · cited 4× · PMID 37915617 · DOI 10.2147/jhc.s395080
8. Neoadjuvant systemic therapy for hepatocellular carcinoma: challenges and opportunities-a narrative review.
   Zhang Y, Yue S, Zhang B, Chen X, et al · · 2025 · cited 2× · PMID 41104208 · DOI 10.21037/hbsn-24-175