Pikeun pasien anu teu tiasa dirawat karsinoma hepatosél (HCC), pilihan perawatan lini kahiji diwatesan, kalebet ablasi lokal, terapi diarahkeun arteri, atanapi terapi radiasi éksternal atanapi kémoterapi. Sorafenib (Dogime) ayeuna mangrupikeun hiji-hijina sistem anu disatujuan pikeun penderita HCC anu teu tiasa dicabut. Rencana perlakuan séksual. Taun 2017, FDA nyatujuan regorafenib (Stivarga) sareng nivolumab (Opdivo) salaku pilihan perawatan kadua pikeun pasien anu saacanna nampi sorafenib. Para panalungtik yakin yén kombinasi Inhibitor PD-L1 durvalumab (Imfinzi) sareng CTLA-4 inhibitor tremelimumab tiasa janten kombinasi perlakuan klinis anu paling pas.
A randomized, multicenter, fase III percobaan HIMALAYA (NCT03298451) dibagi saméméhna untreated, penderita HCC unresectable kana opat grup: 2 durvalumab béda digabungkeun jeung tremelimumab regimens perlakuan digabungkeun, durvalumab monotherapy jeung sorafenib Monoterapi (gambar). Para panalungtik ngagunakeun sakabéh survival (OS) salaku titik tungtung primér sarta waktu progression, progression-gratis survival (PFS), sarta laju respon obyektif (ORR) salaku titik tungtung sekundér.
Durvalumab 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 immunotherapy drugs to achieve the ultimate anti-tumor effect. It is expected that there will be better clinical results.
