About this trial
To observe and evaluate the efficacy and safety of adebrelimab combination chemotherapy regimen in the perioperative treatment of surgically resectable gastric cancer/adenocarcinoma of the gastroesophageal junction.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients voluntarily enrolled in the study and signed an informed consent form
18-75 years old, male and female gender are not limited
Gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction as determined by pathologic histology
Clinical staging of II-III/T3-4aNxM0 (AJCC 8th edition cTNM staging of gastric cancer)
Disqualifiers
patients who are pregnant or breastfeeding
Received prior anti-tumor therapy, including chemotherapy, radiotherapy, targeted therapy, or immunotherapy
other malignant tumor (except basal or squamous cell carcinoma, superficial bladder cancer, cervical cancer in situ or breast cancer) within the past 5 years
Uncontrolled pleural effusion, pericardial effusion or ascites
Trial design
Single group
Treatments tested in this trial
Adebrelimab
DrugAdebrelimab:1200 mg, iv, d1
XELOX
Drugoxaliplatin: 130 mg/m2,iv,d1; capecitabine: 1000 mg/m2,po,pid,d1-d14
Treatment groups
Trial outcomes
Primary outcomes
Pathological completeresponse, pCR
Disappearance of tumor cells from resected specimen
Secondary outcomes
Major Pathological response, MPR
the percentage of tumor cells before and after treatment was compared according to biopsy specimens before neoadjuvant therapy and pathological specimens after surgery; the percentage of tumor cells was evaluated on resected tumor slides. MPR was defined as ≤ 10% tumor cells.
Objective response rate,ORR
Defined as proportion of patients who have a best response of CR or PR
R0 resection rate
Patients who underwent radical resection as a percentage of the total number of patients who underwent surgical resection
Event Free Survival, EFS
From date of surgery until the date of recurrence detection.
Sponsors and contacts
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