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NCT04268888: TACE-3
Nivolumab in Combination With TACE/TAE for Patients With Intermediate Stage HCC
Phase 2, PHASE3 trial testing Nivolumab and TACE/TAE in Hepatocellular Carcinoma in 522 participants. Suspended.
1 August 2025
Quick facts
| Lead sponsor | The Clatterbridge Cancer Centre NHS Foundation Trust |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Suspended |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 522 |
| Start date | 8 May 2019 |
| Primary completion | 1 August 2025 |
| Estimated completion | 30 June 2026 |
| Sites | 2 locations across France, United Kingdom |
Drugs / interventions tested
- Nivolumab and TACE/TAE — full drug profile →
- TACE/TAE
Conditions studied
- Hepatocellular Carcinoma — all drugs for Hepatocellular Carcinoma →
Sponsor
The Clatterbridge Cancer Centre NHS Foundation Trust
Who can join
16 and older, any sex, with Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study evaluates the addition of nivolumab to TACE/TAE in the treatment of patients with intermediate stage hepatocellular carcinoma. All patients will receive TACE/TAE and half will receive nivolumab.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Advances in immunotherapy for hepatocellular carcinoma.
Sangro B, Sarobe P, Hervás-Stubbs S, Melero I. · · 2021 · cited 1002× · PMID 33850328 · DOI 10.1038/s41575-021-00438-0 -
Tumor Immune Microenvironment and Immunosuppressive Therapy in Hepatocellular Carcinoma: A Review.
Oura K, Morishita A, Tani J, Masaki T. · · 2021 · cited 340× · PMID 34071550 · DOI 10.3390/ijms22115801 -
Emerging Therapies for Hepatocellular Carcinoma (HCC).
Chakraborty E, Sarkar D. · · 2022 · cited 236× · PMID 35681776 · DOI 10.3390/cancers14112798 -
Emerging immunotherapy for HCC: A guide for hepatologists.
Foerster F, Gairing SJ, Ilyas SI, Galle PR. · · 2022 · cited 185× · PMID 35253934 · DOI 10.1002/hep.32447 -
Hepatocellular Carcinoma Immune Landscape and the Potential of Immunotherapies.
Giraud J, Chalopin D, Blanc JF, Saleh M. · · 2021 · cited 172× · PMID 33815418 · DOI 10.3389/fimmu.2021.655697 -
Hepatocellular carcinoma: signaling pathways and therapeutic advances.
Zheng J, Wang S, Xia L, Sun Z, et al · · 2025 · cited 142× · PMID 39915447 · DOI 10.1038/s41392-024-02075-w -
Pathogenesis and Current Treatment Strategies of Hepatocellular Carcinoma.
Tümen D, Heumann P, Gülow K, Demirci CN, et al · · 2022 · cited 111× · PMID 36551958 · DOI 10.3390/biomedicines10123202 -
Recent advances in the management of hepatocellular carcinoma.
Sankar K, Gong J, Osipov A, Miles SA, et al · · 2024 · cited 109× · PMID 37482076 · DOI 10.3350/cmh.2023.0125
Verify or expand the search:
- PubMed search for NCT04268888
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Hepatocellular Carcinoma
Currently open trials in the same condition.
- NCT06902246 — Regorafenib and Yttrium-90 Radioembolization for Unresectable Hepatocellular Carcinoma · Phase 2 · recruiting
- NCT05842174 — Targeting Ischemia-Induced Autophagy Dependence in Hepatocellular Carcinoma · Phase 1, PHASE2 · recruiting
- NCT07417397 — Adjuvant TACE in HCC With High-risk Recurrence Factors · Phase 3 · recruiting
- NCT07317414 — β-alanine in the Treatment of Advanced Hepatocellular Carcinoma · Phase 2 · recruiting
- NCT07148050 — Immunotherapy for Solid Tumor Malignancies in Pediatrics Using Interleukin-15 and -21 Armored Glypican-3-specific Chimer · Phase 1 · recruiting
Other The Clatterbridge Cancer Centre NHS Foundation Trust trials
Trials by the same sponsor.
- NCT07342335 — Breaking Barriers to Research Access · recruiting
- NCT07335120 — A Real-world Data and Sample Compendium of Frail and/or Multiply Treated Large B-cell Lymphoma · recruiting
- NCT04603105 — CCP Cancer UK Companion Study · active not recruiting
- NCT04622761 — Phase II Study of the Use of Neoadjuvant Cabazitaxel With Hormonal Treatment in Patients Operable Prostate Cancer, Asses · Phase 2 · not yet recruiting
- NCT03721757 — CA209-891: Neoadjuvant and Adjuvant Nivolumab as Immune Checkpoint Inhibition in Oral Cavity Cancer · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04268888 (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 The Clatterbridge Cancer Centre NHS Foundation Trust
- Last refreshed: 26 February 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/NCT04268888.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing