Bukaannada aan la soo saari karin kansarka hepatocellular (HCC), ikhtiyaarada daawaynta safka hore waa xadidan yihiin, oo ay ku jiraan ka saarida deegaanka, daawaynta ku jihaysan halbowlaha, ama daaweynta shucaaca dibadeed ama kiimoterabiga. Sorafenib (Dogime) hadda waa nidaamka kaliya ee la ansixiyay ee bukaanada qaba HCC aan la sixi karin. Qorshaha daaweynta galmada. 2017, FDA waxay ansixisay regorafenib (Stivarga) iyo nivolumab (Opdivo) inay yihiin ikhtiyaarka daawaynta safka labaad ee bukaanada horey u helay sorafenib. Cilmi-baarayaashu waxay aaminsan yihiin in isku-dhafka PD-L1 xakameyn durvalumab (Imfinzi) iyo CTLA-4 inhibitor tremelimumab ayaa noqon kara isku darka daawaynta caafimaad ee ugu habboon.
A randomized, multicenter, wejiga III HIMALAYA tijaabo (NCT03298451) loo qaybiyey hore aan la daawayn, bukaanka HCC aan la sifayn karin afar kooxood: 2 durvalumab kala duwan oo lagu daray tremelimumab isku darka hababka daaweynta, durvalumab monotherapy iyo sorafenib monotherapy (sawirka). Cilmi-baarayaashu waxay adeegsadeen badbaadada guud (OS) sida barta ugu dambeysa ee ugu dambeysa iyo waqtiga horumarka, badbaadada horumarka-free (PFS), iyo heerka jawaabta ujeeddada (ORR) oo ah dhibcaha ugu dambeeya.
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 buro 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.