Vir pasiënte met onopereerbare Hepatosellulêre karsinoom (HCC), is die eerstelyn behandelingsopsies beperk, insluitend plaaslike ablasie, arteriële gerigte terapie, of eksterne bestralingsterapie of chemoterapie. Sorafenib (Dogime) is tans die enigste goedgekeurde stelsel vir pasiënte met nie-opereerbare HCC. Seksuele behandelingsplan. In 2017 het die FDA regorafenib (Stivarga) en nivolumab (Opdivo) goedgekeur as tweedelynbehandelingsopsies vir pasiënte wat voorheen sorafenib ontvang het. Die navorsers glo dat die kombinasie van PD-L1 inhibeerder durvalumab (Imfinzi) en CTLA-4 inhibeerder tremelimumab kan die mees geskikte kliniese behandeling kombinasie wees.
'n Ewekansige, multisentrum fase III HIMALAYA-proef (NCT03298451) het voorheen onbehandelde, onopereerbare HCC-pasiënte in vier groepe verdeel: 2 verskillende durvalumab gekombineer met tremelimumab gekombineerde behandelingsregimes, durvalumab monoterapie en sorafenib Monoterapie (foto). Die navorsers het algehele oorlewing (OS) as die primêre eindpunt en tyd tot progressie, progressievrye oorlewing (PFS) en objektiewe reaksietempo (ORR) as die sekondêre eindpunte gebruik.
Durvaluumab is a human IgG monoclonal antibody, a PD-L1 inhibitor that binds to PD-1 and CD80, allowing T cells to recognize and kill tumor cells without the need for antibody-dependent and cell-mediated cytotoxic activity. Tremelimumab has a similar mechanism, inhibiting CTLA-4, a cell surface receptor mainly expressed in activated T cells. The hypothesis is that inhibition of CTLA-4 will increase the activity of PD-L1 inhibitors.
In the previous phase I / II study, 40 patients with HCC evaluated the safety and tolerability of the combination. The confirmed ORR was 17.5%, of which 7 patients had partial responses (7/40 patients), and the median response time was 8 weeks. The combination is well tolerated and there is no danger signal in patients with unrespectable HCC. Subsequent research is also underway. This is achieved through the synergistic effect of the two immunotherapie drugs to achieve the ultimate anti-tumor effect. It is expected that there will be better clinical results.
