A Phase II Study to Investigate the Efficacy and Safety of Oral intake of Anamorelin in Patients After Total Gastrectomy

Bando Etsuro0 sites65 target enrollmentApril 20, 2023

Overview

No summary available.

Registry

who.int

Start Date

April 20, 2023

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

Bando Etsuro

•1\) Total gastrectomy for gastric cancer has been performed for more than 1 year and no evident recurrence is observed.
•2\) Histologically diagnosed gastric cancer (special type is acceptable) at the time of surgery.
•3\) Total gastrectomy with D1\+, D2, D2\+ No. 10 lymph node dissection or D2\+PAND, and there was no residual cancer macroscopically at the time of surgery (residual tumor at surgery was R0 or R1\).
•4\) Any distance of esophageal involvement, with the exception of cases of right open chest with concomitant sub\-total esophagectomy.
•5\) The surgical approach performed was one of the following.
•1 Open total gastrectomy was performed regardless of the degree of preoperative
•clinical staging.
•2 Laparoscopic or robot\-assisted total gastrectomy was performed regardless of the
•degree of the preoperative clinical staging. The operator or teaching assistant for laparoscopic or robot\-assisted surgery must be performed by the surgeon technically certified by the Japanese Society for Endoscopic Surgery.
•6\) Age at the time of informed consent is 85 years old or younger.

•1\) Diabetes mellitus,cardiopulmonary disease, osteoarthritis, neurological disease, etc., make safe evaluation and intervention difficult.
•2\) Diagnosed with myocardial infarction or unstable angina within 6 months of registration.
•3\) Complicated with psychosis or psychiatric symptoms, and it is judged difficult to participate in clinical trials.
•4\) Diagnosed with dementia.
•5\) Inability to digest or absorb food or oral medications (chronic nausea, vomiting, diarrhea, gastrointestinal obstruction, hypercalcemia, patients under parenteral nutrition management, gastrointestinal organics associated with radiotherapy) disability, etc.)
•6\) Patients receiving the following drugs and foods: clarithromycin, indinavir, itraconazole, nelfinavir, saquinavir, telaprevir, voriconazole, ritonavir\-containing preparations, cobicistat\-containing preparations, carbamazepine, phenytoin, phenobarbital, rifabutin, rifampicin, St. John's wort, containing food, grapefruit.
•7\) Diagnosed with moderate or severe liver dysfunction (Child\-Pugh classification B and C).
•8\) Meet any of the following cardiac function criteria
•1 Angina pectoris or myocardial infarction within the past 3 months
•2 Patients with second\- or third\-degree atrioventricular block

Not specified