OncoMatch/Clinical Trials/NCT05033392
PD-1 Blockade With JS001 Plus Neoadjuvant Chemotherapy for Gastric/Gastroesophageal Junction Cancer
Is NCT05033392 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Toripalimab for stomach neoplasms.
Treatment: Toripalimab — Gastric cancer (GC),including cardia and noncardia gastric cancer, is responsible for over 480,000 new cases in 2020 and an estimated 370,000 deaths, making it the third most frequently diagnosed cancer and the third leading cause of cancer death in China. Majority of patients(63%) are presented with locally advanced gastric cancer (stage Ⅱ/Ⅲ) and the prognosis is poor. Previous studies have shown that patients with pathological complete response(pCR) following neoadjuvant therapy have longer survival. In 2019, Lancet Oncology published the FLOT4-AIO study which testified that perioperative chemotherapy with FLOT (5-FU/LV, oxaliplatin and docetaxel) regimen has improved pCR rate and prolonged progression free survival(PFS) and overall survival(OS) in patients with stage II/III gastric cancer. Moreover, PD-1 blockade such as nivolumab or pembrolizumab in combination with chemotherapy has shown higher objective response rate(ORR) as compared to chemotherapy alone in advanced gastric cancer. The nanoparticle albumin-bound paclitaxel has been recommended as the second-line chemotherapy for unresectable or recurrent gastric cancer based on the Chinese Society of Clinical Oncology(CSCO) guideline. When PD-1 antibody is applied, albumin-bound paclitaxel is considered as a better partner since no pretreatment of corticosteroids is needed. Thus, the investigators plan to conduct a phase II clinical trial to evaluate the efficacy and safety of toripalimab (PD-1 antibody) combined with the FLOAP (albumin-bound paclitaxel, oxaliplatin, fluorouracil and leucovorin) regimen as the perioperative treatment of cT2-4 and/or N+ GC. The primary end point is pCR rate. The secondary end points include disease free survival(DFS), OS, ORR, R0 resection rate, incidence of adverse events(AE).
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Biomarker criteria
Required: PD-L1 (CD274) any tested (testing required; no eligibility threshold specified)
Disease stage
Required: Stage CT3/4A NX, T2 N1-3 (AJCC 8th)
Endoscopic ultrasonography and/or enhanced CT/MRI examination confirmed at the stage of cT3/4a Nx or T2 N1-3, M0(AJCC 8th) before randomization.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-PD-1 therapy
Patients have received prior therapy with anti-PD-1, anti-PD-L1 or anti-CTLA4 agent.
Cannot have received: anti-PD-L1 therapy
Patients have received prior therapy with anti-PD-1, anti-PD-L1 or anti-CTLA4 agent.
Cannot have received: anti-CTLA-4 therapy
Patients have received prior therapy with anti-PD-1, anti-PD-L1 or anti-CTLA4 agent.
Cannot have received: systemic immunostimulatory drug therapy (interferon, IL-2)
Patients have received systemic immunostimulatory drug therapy (including but not limited to interferon or IL-2) within 4 weeks before enrollment or within 5 half-lives of the drug (whichever is shorter);
Lab requirements
Blood counts
Neutrophil count (ANC)≥1.5×l09/L; Platelet (PLT) ≥80×109/L; Hemoglobin (Hb) level ≥9.0 g/L
Kidney function
Serum creatinine (Cr) level ≤1.5×ULN; Creatinine clearance >50 ml/min (Calculated according to the Cockcroft-Gault formula)
Liver function
Total bilirubin level≤1.5×ULN; Alanine aminotransferase (ALT) level≤3×ULN; Aspartate aminotransferase (AST) level ≤3×ULN
Cardiac function
Major cardiovascular diseases, such as New York Heart Association heart disease (level II or higher), myocardial infarction within 3 months before randomization, unstable arrhythmia, or unstable angina [excluded]. Patients with known coronary artery disease, congestive heart failure that does not meet the above criteria, or left ventricular ejection fraction <50% must adopt an optimized and stable medical plan.
Adequate bone marrow and organ function meets the following criteria: ... Major cardiovascular diseases, such as New York Heart Association heart disease (level II or higher), myocardial infarction within 3 months before randomization, unstable arrhythmia, or unstable angina.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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