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NCT04183088
Regorafenib Plus Tislelizumab as First-line Systemic Therapy for Patients With Advanced Hepatocellular Carcinoma
Phase 2 trial testing Tislelizumab+regorafenib for part 1;Tislelizumab+regorafenib for group 1 of part 2; Regorafenib for group 2 of part 2. in Advanced Hepatocellular Carcinoma in 125 participants. Status unknown.
1 March 2024
Quick facts
| Lead sponsor | National Taiwan University Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 125 |
| Start date | 16 December 2020 |
| Primary completion | 1 March 2024 |
| Estimated completion | 1 March 2025 |
| Sites | 1 location across Taiwan |
Drugs / interventions tested
- Tislelizumab+regorafenib for part 1;Tislelizumab+regorafenib for group 1 of part 2; Regorafenib for group 2 of part 2.
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
Combination of anti-angiogenic molecular targeted therapy and anti- programmed cell death -1 immune checkpoint inhibitor (ICI) therapy has shown promising antitumor activity in multiple cancer types, including patients with advanced hepatocellular carcinoma (HCC). The safety profile and optimal dosage of targeted therapy should be carefully evaluated by clinical trials. Regorafenib is one of the standard second-line systemic therapy for advanced HCC. The present study will test the safety and efficacy of combination of regorafenib and tislelizumab, an anti-programmed cell death-1 ICI. The investigator(s) thus hypothesized that combination of tislelizumab and regorafenib is a tolerable regimen and may improve treatment efficacy for patients with advanced HCC. The present study will explore safety and efficacy of the combination of tislelizumab plus regorafenib as first-line therapy for advanced HCC.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
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 -
Biomarkers for diagnosis and therapeutic options in hepatocellular carcinoma.
Chan YT, Zhang C, Wu J, Lu P, et al · · 2024 · cited 158× · PMID 39242496 · DOI 10.1186/s12943-024-02101-z -
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 -
Experience with regorafenib in the treatment of hepatocellular carcinoma.
Granito A, Forgione A, Marinelli S, Renzulli M, et al · · 2021 · cited 97× · PMID 34104211 · DOI 10.1177/17562848211016959 -
Liver Cancer Immunity.
Ilyas SI, Wang J, El-Khoueiry AB. · · 2021 · cited 81× · PMID 32516437 · DOI 10.1002/hep.31416 -
Therapy of Primary Liver Cancer.
Feng M, Pan Y, Kong R, Shu S. · · 2020 · cited 71× · PMID 32914142 · DOI 10.1016/j.xinn.2020.100032 -
Regorafenib plus nivolumab in unresectable hepatocellular carcinoma: the phase 2 RENOBATE trial.
Kim HD, Jung S, Lim HY, Ryoo BY, et al · · 2024 · cited 55× · PMID 38374347 · DOI 10.1038/s41591-024-02824-y
Verify or expand the search:
- PubMed search for NCT04183088
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT04183088 (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: 23 December 2020
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/NCT04183088.
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