About this trial
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
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Patients with unresectable factors, including unresectable tumor causes or unresectable surgical contraindications or refusal of surgery;
Previous or concurrent other malignancy;
Suffering from any chronic or major illness considered intolerable to treatment (eg, severe cardiac disease, uncontrolled hypertension, some degree of hepatic or renal dysfunction, etc.)
Patients who have previous gastrointestinal perforation, abdominal abscess or recent (within 3 months) intestinal obstruction or imaging and clinical symptoms suggestive of intestinal obstruction;
Trial design
Single group
Treatments tested in this trial
nivolumab combined with SOX
Drugnivolumab + SOX (3 cycles) before surgery → radical surgery (D2) → nivolumab + SOX (3 cycles) after surgery → nivolumab monotherapy maintenance (11 cycles);
Treatment groups
Trial outcomes
Primary outcomes
pathological complete response rate (pCR)
pCR
Secondary outcomes
3-year DFS
3-year DFS
Sponsors and contacts
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Xiangdong Cheng
Lead sponsor
Zhejiang Cancer Hospital
Sponsor institution