This study is an open-label, prospective, randomized controlled phase II clinical study. The purpose is to evaluate the efficacy and safety of megestrol acetate oral suspension for patients with cachexia and cStage III gastric/gastroesophageal junction adenocarcinoma who receive neoadjuvant therapy with serplulimab combined with SOX. This study intends to include 48 patients with locally advanced gastric adenocarcinoma who have not received any treatment, meet the diagnosis of cachexia, and are operable as research subjects. It is expected that 32 patients will be included in the experimental group and 16 patients will be included in the control group, with an inter-group ratio of approximately 2:1. After signing the informed consent, the patients will be screened and meet the inclusion and exclusion criteria. The groups will be assigned according to the random results. The patients will receive or not receive megestrol acetate oral suspension during the 3 cycles of serplulimab SOX regimen before surgery. After the second and third cycles of medication, the efficacy of neoadjuvant therapy and the possibility of radical gastric cancer D2 resection will be evaluated by imaging examinations, and radical gastric cancer surgery will be performed within 2-6 weeks after the third dose is completed. The treatment of postoperative patients will be decided by clinicians and patients based on actual clinical diagnosis and treatment. Patients must be given study drug treatment within 7 days after randomization. The dosing window for each cycle after the first dose is ±7 days. Before each dose, patients must complete the corresponding examinations specified in the protocol to assess the safety and tolerability of the treatment. Dosage regimen: * Treatment group: megestrol acetate oral suspension + serplulimab + SOX * Control group: serplulimab + SOX
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
megestrol acetate oral suspension + serplulimab + SOX
serplulimab + SOX
First Affiliated Hospital of Nanjing Medical Unviersity
Nanjing, Jiangsu, China
The proportion of patients whose weight did not decrease
The proportion of subjects with a weight loss of no more than 2 kg from the initiation of neoadjuvant therapy to the time immediately preceding radical surgery.
Time frame: From the date of the first neoadjuvant therapy until the date of radical surgery,assessed up to 6 months
appetite improve
The proportion of subjects whose appetite improved based on the anorexia/cachexia subscale-12,A/CS-12 scale during neoadjuvant treatment, The total score ranges from 0 to 48, with lower scores indicating poorer appetite status in patients.
Time frame: From the date of the first neoadjuvant therapy until the date of radical surgery,assessed up to 6 months
Quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire(EORTC QLQ-C30)
The total score of this scale ranges from 0 to 100. The higher the score of the functional scale or the overall quality of life, the better the function or overall quality of life.
Time frame: From the date of the first neoadjuvant therapy until the date of radical surgery,assessed up to 6 months
CRP indicators
The level of change in CRP during neoadjuvant treatment.
Time frame: From the date of the first neoadjuvant therapy until the date of radical surgery,assessed up to 6 months
IL-6 indicators
The level of change in IL-6 during neoadjuvant treatment.
Time frame: From the date of the first neoadjuvant therapy until the date of radical surgery,assessed up to 6 months
TNF-α indicators
The level of change in TNF-α during neoadjuvant treatment.
Time frame: From the date of the first neoadjuvant therapy until the date of radical surgery,assessed up to 6 months
serum nutritional indicators (albumin, hemoglobin)
The level of change in nutritional indicators (albumin, hemoglobin) during neoadjuvant treatment.
Time frame: From the date of the first neoadjuvant therapy until the date of radical surgery,assessed up to 6 months
The level of change in L3 skeletal muscle index (L3 SMI)
The level of change in L3 skeletal muscle index (L3 SMI) during neoadjuvant treatment.
Time frame: From the date of the first neoadjuvant therapy until the date of radical surgery,assessed up to 6 months
The number of completed neoadjuvant treatment cycles
Three cycles of neoadjuvant therapy are planned, with assessment of whether the number of cycles is reduced due to reasons such as subject intolerance.
Time frame: From the date of the first neoadjuvant therapy until the date of radical surgery,assessed up to 6 months
The number of the occurrence of drug dose reduction
A drug dosage reduction of more than 15% is defined as a dosage reduction.
Time frame: From the date of the first neoadjuvant therapy until the date of radical surgery,assessed up to 6 months
pathological response
Pathological complete remission (pCR) rate:It is defined as the absence of grossly visible tumor residue in gastric cancer resection specimens following neoadjuvant therapy, with no tumor cells identified microscopically after extensive sampling of the primary tumor site.
Time frame: Assessment shall be completed within one week following radical surgery.
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