NCT05739045 Nivolumab Combined With SOX Used in the Perioperative Treatment
| NCT ID | NCT05739045 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Xiangdong Cheng |
| Condition | Immune Suppression |
| Study Type | INTERVENTIONAL |
| Enrollment | 46 participants |
| Start Date | 2022-11-03 |
| Primary Completion | 2024-12-31 |
Trial Parameters
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Brief Summary
To evaluate the pathological complete response rate (pCR) of nivolumab combined with SOX (oxaliplatin + S-1) for neoadjuvant therapy of resectable gastric and gastroesophageal junction adenocarcinoma;
Eligibility Criteria
Inclusion Criteria: Patients must meet all of the following inclusion criteria to be enrolled in the study: 1\. Patients voluntarily participate in the study and sign the informed consent form; 2. Age ≥ 18 years and ≤ 75 years; 3. Have pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma; 4. Patients with gastric or gastroesophageal junction adenocarcinoma at the clinical staging of cT3-4 or N+, M0 (staging according to AJCC version 8) who could be radically resected as determined by CT and laparoscopy; 5. Have not received anti-tumor therapy (such as surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.); 6. Planned surgical treatment after completion of neoadjuvant therapy; 7. Able to swallow tablets normally; 8. ECOG score 0-1; 9. Expected survival \>=12 months; 10. Main organ functions normal, i.e., meeting the criteria below: 1. Blood routine examination criteria shall meet: (No blood transfusion or blood products within