Status:
RECRUITING
Adebrelimab Combined With SOX Regimen in Preoperative Neoadjuvant Transformation Therapy for Locally Advanced Gastric Adenocarcinoma
Lead Sponsor:
Yang Jianjun, PhD
Conditions:
Locally Advanced Gastric Adenocarcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
Abstract Objective: Adebrelimab is a PD-L1 inhibitor. The aim of this trial is to evaluate the safety and efficacy of adebrelimab combined with SOX regimen for preoperative neoadjuvant therapy in loca...
Eligibility Criteria
Inclusion
- The inclusion criteria is as follows:
- Patients are able to and willing to provide written informed consent to participate in the study.
- Patients are aged 18-75 years old with an Eastern Cooperative Oncology Group (ECOG) score: 0-1 points and expected survival time ≥ 12 weeks.
- Patients are diagnosed with gastric adenocarcinoma by pathological examination and the clinical stage should be clinical stage III (T3-4a/N+M0, T3-4a/N-M0), the tumor of the patients with adenocarcinoma of the gastroesophageal junction should be not involve the dentate line.
- Functions of the major organs and bone marrow meet the following criteria within 7 days before treatment: hemoglobin ≥ 90g/L, absolute neutrophil count ≥ 1.5 × 109/L, platelet (PLT) ≥ 80× 109/L, without blood transfusion within 14 days, total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN), Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5x ULN, serum creatinine ≤ 1.5x ULN or creatinine clearance ≥ 60mL/min.
- Doppler ultrasound: Left ventricular ejection fraction (LVEF) ≥ lower limit of normal value (50%).
- Have not received anti-tumor treatment (such as surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy).
- The exclusion criteria is as follows:
- Other malignant tumors that have occurred or are currently present within 5 years, excluding cured cervical cancer in situ, non-melanoma skin cancer, and superficial bladder tumors.
- Patients who require systemic treatment with corticosteroids (\>10mg prednisone equivalent dose per day) or other immunosuppressive drugs within 14 days before the start of treatment.
- Patients with significant malnutrition. Patients receiving live/attenuated vaccines during treatment. Patients with any severe and/or uncontrollable diseases, including hypertension who cannot be well controlled with antihypertensive medication (systolic blood pressure ≥ 150mm Hg, diastolic blood pressure ≥ 100mm Hg); grade I or above myocardial ischemia or infarction, arrhythmia (including QTc ≥ 480ms) and ≥ grade 2 congestive heart failure (New York Heart Association (NYHA) classification); severe or uncontrolled active infections (≥ CTCAE2 level infection); renal failure requires hemodialysis or peritoneal dialysis; patients with a history of immune deficiency, including those who are HIV positive or suffer from other acquired or congenital immune deficiency diseases; poor blood glucose control in diabetes patients (fasting blood glucose (FBG)\>10mmol/L); patients with epileptic seizures who require treatment; patients with previous and current history of interstitial lung disease, pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe impairment of lung function, etc., may interfere with the detection and management of suspected drug-related pulmonary toxicity; patients with gastrointestinal bleeding, perforation, or obstruction.
- Patients with any bleeding event ≥ CTCAE3 level within the first 4 weeks of enrollment, as well as patients with unhealed wounds, ulcers, or fractures.
- Patients who have experienced arterial/venous thrombosis events within 3 months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis and pulmonary embolism.
- Patients who are preparing to undergo or have previously received allogeneic organ or bone marrow transplantation.
- According to the judgment of the researchers, patients with other accompanying diseases that seriously endanger patient safety or affect the completion of the study.
Exclusion
Key Trial Info
Start Date :
December 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT06192186
Start Date
December 30 2023
End Date
December 31 2025
Last Update
January 29 2024
Active Locations (1)
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1
The First Affiliated Hospital of the Air Force Medical University
Xi'an, China