A Phase II Trial of Perioperative Adebrelimab Combined With XELOX in Resectable Locally Advanced … (NCT06506292) | Clinical Trial Compass
RecruitingPhase 2
A Phase II Trial of Perioperative Adebrelimab Combined With XELOX in Resectable Locally Advanced Gastric/Gastroesophageal Junction Cancer (GC/GEJC)
China25 participantsStarted 2024-07-01
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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)
✓. Clinically judged to be surgically resectable
✓. have at least one measurable lesion (according to the requirements of RECISTv1.1, the long diameter of spiral CT scan of this measurable lesion is ≥10mm or the short diameter of enlarged lymph node is ≥15mm)
✓. No other anti-tumor therapy has been received
✓. ECOG score:0\~1
Exclusion criteria
✕. 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
What they're measuring
1
Pathological completeresponse, pCR
Timeframe: After surgical excision with follow up of an average of 1 year
Trial details
NCT IDNCT06506292
SponsorTianjin Medical University Cancer Institute and Hospital
. Clinically determined to be inoperable or with distal metastasis
✕. Severe cardiovascular disease, such as symptomatic coronary artery disease, class ≥II congestive heart failure, uncontrolled arrhythmia, myocardial infarction, within 12 months prior to enrollment.
✕. Complicated upper gastrointestinal tract obstruction/bleeding or digestive dysfunction or malabsorption syndrome
✕. History of gastrointestinal perforation in the 6 months prior to enrollment