A 2018 Gastrointestinal Cancer Symposium, sakamakon gwaji na Phase III CELESTIAL ya nuna cewa idan aka kwatanta da placebo, carbotinib zai iya inganta rayuwar gaba ɗaya (OS) na marasa lafiya da aka bi da su a baya tare da ciwon hanta (HCC) ta watanni 2.2.
A cikin gwajin makafi sau biyu, lokacin rayuwa na tsaka-tsaki don carbotinib shine watanni 10.2 idan aka kwatanta da watanni 8.0 don placebo, wanda ke nufin raguwar 24% cikin haɗarin ci gaba ko mutuwa. Rayuwa ba tare da ci gaba ba (PFS) tare da cattinib shine watanni 5.2, kuma placebo shine watanni 1.9, kuma haɗarin ci gaba ko mutuwar maganin da aka yi niyya ya ragu da kashi 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.
A cikin gwajin CELESTIAL, an ba da marasa lafiya 707 bazuwar zuwa 60 MG na carbatinib (n = 470) ko placebo (n = 237) kowace rana. Duk marasa lafiya suna da matsayi na aikin ECOG 0 ko 1. Akalla an yi maganin tsarin tsarin, kuma 70% na marasa lafiya sun yi amfani da sorafenib (Nexavar).
A cikin nazarin ƙungiyar sorafenia, matsakaicin OS a cikin ƙungiyar carbotinib shine watanni 11.3, idan aka kwatanta da watanni 7.2 a cikin rukunin placebo; PFS na tsakiya shine watanni 5.5 da watanni 1.9 a cikin rukunin placebo.
AEs masu alaƙa da jiyya (16%) idan aka kwatanta da placebo (3%), ƙarin marasa lafiya sun daina jiyya. Mafi yawan abubuwan da suka faru mara kyau na 3-4 (AEs) da kasatinib akan placebo sune jajayen dabino mara kyau (17% vs 0%), hauhawar jini (16% vs 2%), da haɓakar aspartate aminotransferase (12% vs 7%), gajiya. (10% vs 4%) da gudawa (10% vs 2%). Idan aka kwatanta da placebo, abin da ya faru na aji 5 AE a cikin ƙungiyar carbotinib ya kasance mafi girma. Gabaɗaya, marasa lafiya 6 sun kamu da gazawar hanta, fistula bronchial, thrombosis portal vein thrombosis, zub da jini na sama na gastrointestinal, kumburin huhu, da ciwon hanta. Daya majiyyaci a cikin rukunin placebo ya mutu sakamakon gazawar hanta.
