Combining Adebrelimab with SOX regimen for treating advanced gastric cancer before surgery

The Safety and Efficacy of Adebrelimab Combined With SOX Regimen in Preoperative Neoadjuvant Therapy for Locally Advanced Gastric Adenocarcinoma Patients (ASOG-01)

This study is testing if adding a new drug called adebrelimab to the standard SOX treatment can help people with advanced stomach cancer before they have surgery.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Xijing Hospital (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, radiation, prednisone, Adebrelimab
• Locations: 1 site (Xi'an)
• Trial ID: NCT06192186 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of adebrelimab, a PD-L1 inhibitor, when combined with the SOX regimen (S-1 and oxaliplatin) as a preoperative neoadjuvant therapy for patients with locally advanced gastric adenocarcinoma. The study is a prospective, single-center, double-blind, randomized controlled trial involving 110 patients, who will be divided into two groups: one receiving the combination treatment and the other receiving the SOX regimen alone. The primary goal is to assess the pathological complete response rate, while secondary outcomes include surgical safety, disease-free survival, and overall survival rates.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with clinical stage III gastric adenocarcinoma and an ECOG score of 0-1.

Not a fit: Patients with earlier-stage gastric cancer or those with significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve surgical outcomes and survival rates for patients with locally advanced gastric adenocarcinoma.

How similar studies have performed: Other studies have shown promise with similar immunotherapy approaches in cancer treatment, indicating potential for success in this trial.

Eligibility criteria

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.

Where this trial is running

Xi'an

• The First Affiliated Hospital of the Air Force Medical University — Xi'an, China (Recruiting)

Study contacts

• Study coordinator: Jianjun Yang, professor

Conditions Locally Advanced Gastric Adenocarcinoma; Adebrelimab; SOX regimen; Preoperative neoadjuvant transformation therapy; Locally advanced gastric adenocarcinoma; Randomized controlled clinical trial