JPRN-jRCTs031230646招募中2 期
An exploratory randomized controlled trial of the clinical efficacy of anamorelin hydrochloride in patients after radical surgery for upper gastric cancer and esophagogastric junction cancer - a phase II trial
Matsumoto Yasunori0 个研究点目标入组 30 人开始时间: 2024年2月20日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Adults 18 years of age or older at the time of consent
- •2) Patients with a histological diagnosis of gastric adenocarcinoma or adenocarcinoma of the esophagogastric junction
- •3) Patients who have undergone a gastrectomy or total gastrectomy as radical surgical treatment
- •4) Patients with ECOG Performance Status 0-2
- •5) Patients with preserved major organ function (heart, lungs, liver, kidneys, etc.)
- •6) Patients who can start taking the study drug within 8 weeks after surgery
- •7) Patients who have been fully informed of the study and who have given written consent of their own free will after full understanding of the study.
排除标准
- •) Patients who have difficulty taking food orally
- •2) Patients with other cancers requiring treatment
- •3) Patients who have undergone preoperative chemotherapy
- •4) Patients with postoperative complications (Clavien-Dindo classification IIIa or higher) from gastric cancer surgery
- •5) Patients for whom postoperative adjuvant chemotherapy is recommended in the guidelines for the treatment of gastric cancer.
- •6) Patients with hypersensitivity to anamorelin hydrochloride in the past
- •7) Patients who received anamorelin hydrochloride within 12 weeks prior to the start of study drug administration
- •8) Patients with severe conduction disturbances (e.g., complete atrioventricular block)
- •9)Patients with poorly controlled diabetes
- •10) Patients receiving the following drugs
- •clarithromycin, itraconazole, voriconazole, ritonavir-containing preparations, cobicistat-containing preparations, encitrelvir fumarate
- •11)Patients who are pregnant, possibly pregnant, within 28 days postpartum, or lactating
- •12) Other patients who are judged by the principal investigator or subinvestigator to be inappropriate for the safe conduct of this study.
研究者
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