OncoMatch/Clinical Trials/NCT05165407
Sintilimab Combined With IBI310 and Surufatinib for the Treatment of G3-NET and NEC (NESSIE)
Is NCT05165407 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Sintilimab and IBI310 for neuroendocrine neoplasm.
Treatment: Sintilimab · IBI310 · Surufatinib — This is a phase II, single arm, open-label, multicenter study to evaluate the efficacy and safety of Sintilimab combined with IBI310 and Surufatinib for the treatment of high-grade advanced-neuroendocrine neoplasm
Check if I qualifyExtracted eligibility criteria
Cancer type
Neuroendocrine Tumor
Biomarker criteria
Required: PD-L1 (CD274) expression (testing required; no eligibility threshold specified)
Agree to provide tumor specimens (for further diagnosis of pathological grade, detection of PD-L1 expression and lymphocyte infiltration)
Disease stage
Grade: high-grade (ki67 index > 20% or mitotic count > 20/hpf)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard treatment
Patients who failed to receive standard treatment (Have progressed on previous treatment, or treatment toxicity and side effects are not tolerated), or cannot receive standard treatment (including patients who are intolerant to standard treatment, who are judged by the investigator to be unsuitable for standard treatment or who refuse to receive standard treatment), or who have no standard treatment plan
Cannot have received: anti-PD-1 therapy
Previous use of anti (PD-1), anti-PD-L1, anti-PD-L2 or CTLA-4 antibody or any other antibody acting on T cell co-stimulatory or checkpoint pathways (including but not limited to OX-40, CD137, etc.), anti-VEGF/VEGFR-targeted drugs
Cannot have received: anti-PD-L1 therapy
Previous use of anti (PD-1), anti-PD-L1, anti-PD-L2 or CTLA-4 antibody or any other antibody acting on T cell co-stimulatory or checkpoint pathways (including but not limited to OX-40, CD137, etc.), anti-VEGF/VEGFR-targeted drugs
Cannot have received: anti-PD-L2 therapy
Previous use of anti (PD-1), anti-PD-L1, anti-PD-L2 or CTLA-4 antibody or any other antibody acting on T cell co-stimulatory or checkpoint pathways (including but not limited to OX-40, CD137, etc.), anti-VEGF/VEGFR-targeted drugs
Cannot have received: anti-CTLA-4 therapy
Previous use of anti (PD-1), anti-PD-L1, anti-PD-L2 or CTLA-4 antibody or any other antibody acting on T cell co-stimulatory or checkpoint pathways (including but not limited to OX-40, CD137, etc.), anti-VEGF/VEGFR-targeted drugs
Cannot have received: anti-VEGF/VEGFR-targeted drugs
Previous use of anti (PD-1), anti-PD-L1, anti-PD-L2 or CTLA-4 antibody or any other antibody acting on T cell co-stimulatory or checkpoint pathways (including but not limited to OX-40, CD137, etc.), anti-VEGF/VEGFR-targeted drugs
Lab requirements
Blood counts
ANC ≥1.5x10^9/L (no G-CSF/hematopoietic factor); Platelets ≥100×10^9/L (no transfusion/blood product); Hemoglobin ≥9 g/dL (no transfusion/erythropoietin)
Kidney function
Serum creatinine ≤1.5×ULN and creatinine clearance rate ≥60 mL/min (Cockcroft-Gault)
Liver function
Total bilirubin ≤1.5 × ULN (if >1.5×ULN, direct bilirubin ≤ ULN allowed); AST, ALT ≤2.5×ULN (≤5×ULN with liver metastasis)
Cardiac function
Myocardial enzyme profile within normal range (unless not clinically significant per investigator)
Patients with adequate organ functions whose laboratory tests within 7 days before the first dose meet the following requirements: ... (see full criteria for details)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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