Gastric Cancer Gastric Cancer, Anamorelin
Conditions
Interventions
Registration and randomization: Performed within 42 days after gastrectomy.
Intervention: Oral administration of anamorelin hydrochloride at 100 mg/day in the morning, for a total duration of 12 weeks
Sponsors
Tanaka Chie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18 or older 2. Gastric cancer with no esophageal invasion or an invasion of 3 cm or less. 3. No remnant gastric cancer. 4. Underwent one of the following surgical procedures: distal gastrectomy, proximal gastrectomy, or total gastrectomy, with R0 resection. 5. No history of abdominal radiotherapy, including treatments for other malignancies, prior to surgery. 6. No history of systemic therapy (chemotherapy, immune checkpoint inhibitors, etc.) for any malignancy prior to surgery. 7. Pathological histological stage is II or III (pStageII or pStageIII), and postoperative adjuvant chemotherapy is scheduled to be performed. 8. Able to start oral administration of anamorelin within 42 days after surgery. 9. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Presence of synchronous or metachronous multiple cancers. 2. Patients with an allergy to anamorelin hydrochloride. 3. Patients with contraindications for anamorelin hydrochloride, including heart failure, myocardial infarction or angina, severe conduction disorders, Liver dysfunction (Child-Pugh classification B or C) 4. Patients who are currently taking or planning to take contraindicated medications, including clarithromycin, indinavir, itraconazole, nelfinavir, saquinavir, telaprevir, voriconazole, ritonavir-containing formulations, or cobicistat-containing formulations. 5. Patients who need to continue using flucytosine (antifungal drug) in combination with S-1 6. Any other patients deemed inappropriate by the doctors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| relative dose intensity (RDI) of S-1 in adjuvant chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. RDI of postoperative adjuvant therapy in the S-1 monotherapy group. 2. RDI of postoperative adjuvant therapy in the DS therapy group (S-1). 3. RDI of postoperative adjuvant therapy in the DS therapy group (DTX). 4. Percentage of body weight loss at 3, 6, and 12 months after surgery compared to preoperative weight. 5. Nutritional status evaluation (using blood biochemistry tests (serum albumin, lymphocyte count, PNI, mGPS, CONUT score) (3, 6, and 12 months after surgery). 6. Changes in lean body mass in body composition (3, 6, and 12 months after surgery). 7. Postoperative quality of life (QOL) assessment using PGSAS-37 and EORTC-QLQ C30 (3, 6, and 12 months after surgery). 8. Overall survival, recurrence-free survival. | — |
Contacts
Public ContactShizuki Sugita
Nagoya University Hospital
Outcome results
None listed