Atezolizumab and bevacizumab with transarterial chemoembolization in hepatocellular carcinoma: the DEMAND trial protocol.
Najib Ben KhaledMax SeidenstickerJens RickeJulia MayerleBettina OehrleDaniel RösslerDaniel TeupserUrsula EhmerMichael BitzerDirk WaldschmidtMartin FuchsPhilipp A ReukenChristian M LangeHenning WegeArne KandulskiAlexander DechêneMarino VeneritoMarie-Luise BerresTom LueddeIlja KubischFlorian P ReiterEnrico N De ToniPublished in: Future oncology (London, England) (2022)
The combination of the anti-PD-L1 antibody atezolizumab and the anti-VEGF bevacizumab is the first approved immunotherapeutic regimen for first-line therapy in patients with unresectable hepatocellular carcinoma (HCC), currently approved in more than 80 countries. The efficacy and tolerability of this regimen suggest that the use of atezolizumab + bevacizumab could be extended to the treatment of patients with intermediate-stage HCC in combination with transarterial chemoembolization (TACE). The authors describe the rationale and design of the DEMAND study. This investigator-initiated, multicenter, randomized phase II study is the first trial to evaluate the safety and efficacy of atezolizumab + bevacizumab prior to or in combination with TACE in patients with intermediate-stage HCC. The primary end point is the 24-month survival rate; secondary end points include objective response rate, progression-free survival, safety and quality of life. Clinical Trial Registration: NCT04224636 (ClinicalTrials.gov).
Keyphrases
- open label
- phase iii
- phase ii study
- phase ii
- clinical trial
- double blind
- free survival
- placebo controlled
- metastatic colorectal cancer
- study protocol
- radiofrequency ablation
- liver metastases
- randomized controlled trial
- locally advanced
- radiation therapy
- stem cells
- squamous cell carcinoma
- cross sectional
- replacement therapy