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

JRCT ID: jRCTs031230646

Registered date:20/02/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Gastric cancer, Esophagogastric junction cancer
• Date of first enrollment: 20/02/2024
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Eligible postoperative gastric and esophagogastric junction cancer patients will receive the study drug for 4 weeks in addition to usual nutritional management and be followed up to 24 weeks postoperatively.

Outcome(s)

• Primary Outcome: Preoperative weight loss at 24 weeks postoperatively

Secondary Outcome

(1) Percentage of patients with preoperative weight loss of 15% or more at 24 weeks postoperatively
(2) The following items at 12 weeks postoperatively
a) Nutritional indices (CONUT score, TP, Alb, lymphocyte count, ChE, T-Cho, CRP)
b) Grip strength
(3)The following items at 24 weeks postoperatively
a) Nutritional indices (CONUT score, TP, Alb, lymphocyte count, ChE, T-Cho, CRP)
b) Grip strength
c) Body composition (lean body mass, PMI on CT)
(4) ONS (oral nutrition supplements) intake during the treatment period
(5) QOL score (PGSAS-37, 45) before and after treatment
(6) Treatment completion rate
(7) Adverse event rate

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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.

Exclude criteria

) 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.

Related Information

• Primary Sponsor: Matsumoto Yasunori
• Source(s) of Monetary Support: Clinical Research Initiation-Fund (of Chiba University Hospital)