Marka la joogo 2018 Symposium Kansarka Gastrointestinal Kansarka, natiijooyinka Wajiga III ee tijaabada CELESTIAL waxay muujisay in marka la barbar dhigo placebo, karbotinib ay hagaajin karto badbaadada guud (OS) ee bukaannada hore loo daaweeyay ee kansarka beerka sare (HCC) bilaha 2.2.
Tijaabada laba-indho-indho-la'aanta ah, wakhtiga badbaadada dhexdhexaadka ah ee carbotinib waxay ahayd 10.2 bilood marka la barbardhigo bilaha 8.0 ee placebo, taas oo macnaheedu yahay 24% hoos u dhigista khatarta horumarka ama dhimashada. Badbaadada aan horumarka lahayn (PFS) ee leh catinib waxay ahayd 5.2 bilood, placebo waxay ahayd 1.9 bilood, khatarta horumarka ama dhimashada daaweynta la beegsaday ayaa hoos loo dhigay 56%.
Based on the results of this study, pharmaceutical companies are preparing to submit an application for approval to the FDA, which was approved for the treatment of kidney cancer and thyroid cancer. The prognosis of patients with advanced hepatocellular carcinoma is poor, and previous systemic treatments are limited. Principal Investigator Ghassan K, MD, MD, Memorial Sloan Kettering Cancer Center, said that in clinical trials, the significant benefits for patients ’overall survival and progression-free survival indicate that if approved, carbatinib can become an important treatment for these patients Complementary therapy.
Tijaabada CELESTIAL, bukaanada 707 ayaa si aan kala sooc lahayn loogu qoondeeyay 60 mg of carbatinib (n = 470) ama placebo (n = 237) maalintii. Dhammaan bukaannadu waxay lahaayeen heerka waxqabadka ECOG 0 ama 1. Ugu yaraan hal daaweyn oo nidaamsan ayaa la sameeyay, 70% bukaannada ayaa isticmaalay sorafenib (Nexavar).
Falanqaynta kooxda sorafenia, dhexdhexaadinta OS ee kooxda karbotinib waxay ahayd 11.3 bilood, marka la barbardhigo bilaha 7.2 ee kooxda placebo; Dhexdhexaadiyaha PFS wuxuu ahaa 5.5 bilood iyo 1.9 bilood kooxda placebo.
AE-yada la xidhiidha daawaynta (16%) marka la barbar dhigo placebo (3%), bukaanno badan ayaa joojiyay daawaynta. Fasalka ugu badan ee 3-4 dhacdooyinka xun xun (AEs) iyo kasatinib ka dhanka ah placebo waa calaacalaha cas oo aan caadi ahayn (17% vs 0%), hypertension (16% vs 2%), iyo aminotransferase aspartate sare (12% vs 7%), daal (10% vs 4%) iyo shuban (10% vs 2%). Marka la barbar dhigo placebo, dhacdooyinka fasalka 5 AE ee kooxda karbotinib ayaa ka sarreeyay. Guud ahaan, bukaannada 6 ayaa ku dhacay beerka oo shaqeyn waayay, fistula hunguriga bronki, xinjirowga xididka portal, dhiigbaxa caloosha sare, sambabada sambabada, iyo cilladda xididdada beerka. Hal bukaan oo ka tirsan kooxda placebo ayaa u dhintay beerka oo shaqayn waayey.