NCT04294498 is a Phase 2 clinical trial of Durvalumab in Advanced Hepatocellular Carcinoma, sponsored by National Taiwan University Hospital.

Who is sponsoring NCT04294498?

NCT04294498 is sponsored by National Taiwan University Hospital.

What drugs are being tested in NCT04294498?

Interventions in NCT04294498: Durvalumab.

What condition does NCT04294498 study?

NCT04294498 studies Advanced Hepatocellular Carcinoma.

Is NCT04294498 still recruiting?

NCT04294498 is currently active, enrolled. Last updated 26 March 2025.

Last reviewed 2025-03-26 · How we verify

NCT04294498

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Durvalumab for Advanced Hepatocellular Carcinoma in Patients With Active Chronic Hepatitis B Virus Infection

Active, enrolled Phase 2 Last updated 26 March 2025

What this trial tests

Phase 2 trial testing Durvalumab in Advanced Hepatocellular Carcinoma in 30 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

2 November 2020

Primary endpoint
1 September 2024

1 September 2026

Quick facts

Lead sponsor	National Taiwan University Hospital
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	2 November 2020
Primary completion	1 September 2024
Estimated completion	1 September 2026
Sites	1 location across Taiwan

Drugs / interventions tested

Durvalumab — full drug profile →

Conditions studied

Advanced Hepatocellular Carcinoma — all drugs for Advanced Hepatocellular Carcinoma →

Sponsor

National Taiwan University Hospital

Who can join

20 and older, any sex, with Advanced Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

PD1 blockade has been approved as salvage therapy for advanced hepatocellular carcinoma (HCC). Although there is not solid evidence that PD1 blockade would induce hepatitis B virus (HBV) reactivation, previous clinical trials of PD1 blockade required enrolled patients to receive anti-HBV medications and control the viral load to be under 100-2000 IU/mL before initiation of PD1 blockade therapy. Such a requirement may not be necessary and could delay the treatment. Guidelines for prevention of chemotherapy induced HBV reactivation only suggest combining anti-HBV medications during the chemotherapy course without such a requirement of very load HBV viral load. The investigators hypothesized that under anti-HBV medications, patients with advanced HCC and active chronic hepatitis B virus (HBV) infection can receive durvalumab treatment without increased risks of HBV reactivation and related complications.

Publications & conference data

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

Emerging Therapies for Hepatocellular Carcinoma (HCC).
Chakraborty E, Sarkar D. · · 2022 · cited 236× · PMID 35681776 · DOI 10.3390/cancers14112798
Research Status and Outlook of PD-1/PD-L1 Inhibitors for Cancer Therapy.
Ai L, Chen J, Yan H, He Q, et al · · 2020 · cited 149× · PMID 32982171 · DOI 10.2147/dddt.s267433
Tumor Microenvironment of Hepatocellular Carcinoma: Challenges and Opportunities for New Treatment Options.
Sas Z, Cendrowicz E, Weinhäuser I, Rygiel TP. · · 2022 · cited 124× · PMID 35409139 · DOI 10.3390/ijms23073778
Immune Checkpoint Inhibitors for Unresectable Hepatocellular Carcinoma.
Abd El Aziz MA, Facciorusso A, Nayfeh T, Saadi S, et al · · 2020 · cited 57× · PMID 33086471 · DOI 10.3390/vaccines8040616
Viral oncogenesis in cancer: from mechanisms to therapeutics.
Xiao Q, Liu Y, Li T, Wang C, et al · · 2025 · cited 45× · PMID 40350456 · DOI 10.1038/s41392-025-02197-9
Immune Checkpoint Inhibitors in Hepatocellular Carcinoma: An Overview.
van Doorn DJ, Takkenberg RB, Klümpen HJ. · · 2020 · cited 18× · PMID 33374927 · DOI 10.3390/ph14010003
Immune checkpoints on T and NK cells in the context of HBV infection: Landscape, pathophysiology and therapeutic exploitation.
Dumolard L, Aspord C, Marche PN, Macek Jilkova Z. · · 2023 · cited 15× · PMID 37056774 · DOI 10.3389/fimmu.2023.1148111
Hepatitis B Virus Reactivation in Cancer Patients Undergoing Immune Checkpoint Inhibitors Therapy: A Systematic Review.
Zhao J, Zhang Y, Qin S, Zou B, et al · · 2022 · cited 10× · PMID 36484006 · DOI 10.7150/jca.77247

Verify or expand the search:

Other trials of Durvalumab

Trials testing the same drug.

NCT07507968 — TNT With FLOT/Durvalumab Plus Post-OP Durvalumab for Resectable Gastroesophageal Adenocarcinoma · Phase 2 · not yet recruiting
NCT07332351 — Neoadjuvant Intravesical Nadofaragene Firadenovec With Gemcitabine, Cisplatin and Durvalumab for the Treatment of Muscle · Phase 2 · not yet recruiting
NCT07339059 — Phase II Study of Sacituzumab Govitecan With Atezolizumab/Durvalumab as Maintenance Therapy for Extensive-Stage Small Ce · Phase 2 · recruiting
NCT07531095 — Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC) · Phase 1 · not yet recruiting
NCT07459634 — A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC · Phase 2 · not yet recruiting

Other recruiting trials for Advanced Hepatocellular Carcinoma

Currently open trials in the same condition.

NCT07166406 — Testing Immunotherapy With or Without Stereotactic Body Radiation Therapy in Patients With Advanced Liver Cancer, HELIO- · Phase 3 · recruiting
NCT07174570 — Celecoxib, Durvalumab and Tremelimumab for the Treatment of Patients With Advanced or Metastatic Liver Cancer · Phase 2 · recruiting
NCT07227012 — Symbiotic-GI-13: A Study to Learn About Study Medicine Called PF-08634404 as a Single Treatment and Combination Treatmen · Phase 1, PHASE2 · recruiting
NCT06811116 — Testing the Addition of an Anti-cancer Drug, Sapanisertib, to the Usual Chemotherapy Treatment (Cabozantinib) in Metasta · Phase 1, PHASE2 · recruiting
NCT06789848 — Ligufalimab and Cadonilimab in Advanced Liver Cancers · Phase 2 · recruiting

Other National Taiwan University Hospital trials

Trials by the same sponsor.

NCT06936917 — Timing for Computed Tomography and Post-Resuscitation Care on Short-Term Outcomes in Out-of-Hospital Cardiac Arrest · not yet recruiting
NCT05396222 — A Prospective Study of the Safety and Efficacy of 3D-printed Non-rigid Biomimetic Implant in Cervical and Thoracolumbar · NA · not yet recruiting
NCT07532356 — Integrating Tumor Genomics and Urinary Exosomal Proteomics to Establish a Multi-Layer Biomarker Framework for Early Risk · not yet recruiting
NCT07317310 — The NTU JO-SMART Study · NA · not yet recruiting
NCT07382024 — Tirzepatide to Reduce rEcurrence And Burden After Ablation of Atrial Fibrillation · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04294498 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Taiwan University Hospital
Last refreshed: 26 March 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04294498.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing