OncoMatch/Clinical Trials/NCT06341595
Concurrent Chemoradiotherapy Combined With Sintilimab as Neoadjuvant Therapy for GC Patients With PALM
Is NCT06341595 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Sintilimab and Oxaliplatin for gastric cancer.
Treatment: Sintilimab · Oxaliplatin · S-1 — This trial is a prospective, single arm, single center, phase II clinical study aimed at subjects with advanced gastric cancer and para aortic lymph node metastasis, exploring the feasibility and safety of Sintilimab Injection combined with synchronous chemo-radiotherapy as neoadjuvant therapy. Patients will receive sintilimab Injection (200mg iv q3w d1) combined with concurrent radiotherapy and chemotherapy. The chemotherapy regimen will use oxaliplatin 130mg/m2+S-1 40mg/m2 bid d1-14. Radiotherapy is performed using intraperitoneal radiation therapy, once a day, five times a week, at a dose of 1.8-2 Gy/f, for a total of 45-50.4 Gy (60-66 Gy for lymph node lesions). Radiation therapy starts from the second cycle of Sintilimab Injection combined with chemotherapy. The subjects underwent imaging evaluation after completing 4 cycles of combination chemotherapy and radiation therapy with Sintilimab Injection. Evaluated as a surgical subject (surgical conditions: imaging evaluation of enlarged lymph nodes adjacent to the abdominal aorta with PR or no significant activity), radical surgery will be performed within 4 weeks after the last study drug treatment. After surgery, the researcher will determine the necessity of adjuvant treatment and develop an adjuvant treatment plan based on the subject's condition. Subjects evaluated as inoperable will have their best follow-up treatment plan determined by the researcher.
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Biomarker criteria
Excluded: HER2 (ERBB2) positive
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-PD-1 therapy
Has received prior therapy with an anti-programmed death (PD)-1, anti-PD-L1, anti-PD L2 , anti-CD137,anti-CTLA-4 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137)
Cannot have received: anti-PD-L1 therapy
Has received prior therapy with an anti-programmed death (PD)-1, anti-PD-L1, anti-PD L2 , anti-CD137,anti-CTLA-4 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137)
Cannot have received: anti-PD-L2 therapy
Has received prior therapy with an anti-programmed death (PD)-1, anti-PD-L1, anti-PD L2 , anti-CD137,anti-CTLA-4 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137)
Cannot have received: anti-CTLA-4 therapy
Has received prior therapy with an anti-programmed death (PD)-1, anti-PD-L1, anti-PD L2 , anti-CD137,anti-CTLA-4 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137)
Cannot have received: cytotoxic chemotherapy
has not receive previous anti-tumor treatment (radiotherapy, chemotherapy, targeted or immunotherapy, etc.)
Cannot have received: targeted therapy
has not receive previous anti-tumor treatment (radiotherapy, chemotherapy, targeted or immunotherapy, etc.)
Cannot have received: immunotherapy
has not receive previous anti-tumor treatment (radiotherapy, chemotherapy, targeted or immunotherapy, etc.)
Cannot have received: radiation therapy
has not receive previous anti-tumor treatment (radiotherapy, chemotherapy, targeted or immunotherapy, etc.)
Lab requirements
Blood counts
ANC ≥ 1.5x10^9/l without G-CSF in past 14 days; Platelets ≥ 100 × 10^9/l without transfusion in 14 days; Hemoglobin >9g/dl without transfusion or erythropoietin in 14 days
Kidney function
Blood creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 60 ml/min
Liver function
Total bilirubin ≤ 1.5 × ULN; AST and ALT ≤ 2.5 × ULN (≤ 5 × ULN if liver metastasis)
Cardiac function
Good coagulation function (INR or PT ≤ 1.5 × ULN); resting ECG without major uncontrolled abnormalities
sufficient organ function, the subject needs to meet the following laboratory indicators: ... see full criteria
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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