[Translation] An open-label, single-arm, multicenter, phase II clinical trial to evaluate the efficacy, safety and pharmacodynamics of oxbitzine fumarate enteric-coated pellets (SM-1) in the treatment of advanced small bowel adenocarcinoma (SBA) test
1、主要目的:评价富马酸奥比特嗪肠溶微丸胶囊(SM-1)治疗晚期小肠腺癌的有效性。
2、次要目的:
(1)评价富马酸奥比特嗪肠溶微丸胶囊(SM-1)治疗晚期小肠腺癌的安全性;
(2)评价富马酸奥比特嗪肠溶微丸胶囊(SM-1)治疗晚期小肠腺癌的PK、PD特征。
[Translation] 1. Main purpose: To evaluate the efficacy of oxidazine fumarate enteric-coated pellets (SM-1) in the treatment of advanced small bowel adenocarcinoma.
2. Secondary purpose:
(1) To evaluate the safety of Obitrazine fumarate enteric-coated pellets (SM-1) in the treatment of advanced small bowel adenocarcinoma;
(2) To evaluate the PK and PD characteristics of oxbitzine fumarate enteric-coated pellets (SM-1) in the treatment of advanced small bowel adenocarcinoma.