OncoMatch/Clinical Trials/NCT06725498
Intra-arterial Chemotherapy Combined with Radiotherapy and Immunotherapy for HNSCC
Is NCT06725498 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Tislelizumab-jsgr and Cisplatin for head and neck squamous cell carcinoma.
Treatment: Tislelizumab-jsgr · Cisplatin · Albumin-Bound Paclitaxel — This study pioneers a novel approach by integrating a new auxiliary chemo-immunotherapy regimen, which is then followed by an evaluation of the potential for surgical resection. For those patients who remain non-resectable, a tailored treatment plan is proposed, consisting of arterial infusion chemotherapy in conjunction with radiotherapy, succeeded by a series of immune checkpoint inhibitors. The efficacy and safety of this integrated therapeutic strategy are meticulously assessed, with the goal of enhancing survival outcomes for patients with T4bNanyM0 HNSCC.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Disease stage
Required: Stage T4BNANYM0
Patients with T4bNanyM0 Head and neck squamous cell carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: immunotherapy
history of prior immunotherapy
Cannot have received: radiotherapy
history of prior...radiotherapy
Cannot have received: EGFR-targeted therapy
history of prior...treatment with EGFR monoclonal antibodies
Lab requirements
Blood counts
ANC ≥1,000/mcL, platelets ≥75,000/mcL, hemoglobin ≥8g/dL, without transfusion or dependence on erythropoietin (EPO) (within 7 days after assessment)
Kidney function
Serum creatinine ≤1.5 times ULN OR measured or calculated creatinine clearance ≥60mL/min with creatinine levels > 1.5 times the institutional ULN. (GFR can also be used in place of creatinine or CrCl)
Liver function
For subjects with a total bilirubin level >1.5 ULN, serum total bilirubin ≤1.5 times ULN or direct bilirubin ≤ULN; For patients with liver metastases, AST/SGOT and ALT/SGPT ≤2.5 times ULN OR ≤5 times ULN; Albumin > 2.5 mg/dL
Cardiac function
Ejection fraction <40% on 2D echocardiogram (ECHO) at screening [excluded]; Prolonged corrected QT (QTc) interval > 475 ms on screening EKG [excluded]
Adequate bone marrow reserve and organ function: Absolute neutrophil count (ANC) ≥1,000/microliter (mcL), platelets ≥75,000/mcL, hemoglobin ≥8g/dL, without transfusion or dependence on erythropoietin (EPO) (within 7 days after assessment); Renal function: Serum creatinine ≤1.5 times the upper limit of normal (ULN) OR measured or calculated creatinine clearance ≥60mL/min with creatinine levels > 1.5 times the institutional ULN. (GFR can also be used in place of creatinine or CrCl). Creatinine clearance should be calculated according to institutional standards; Liver function: For subjects with a total bilirubin level >1.5 ULN, serum total bilirubin ≤1.5 times ULN or direct bilirubin ≤ULN; For patients with liver metastases, aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤2.5 times ULN OR ≤5 times ULN; Albumin > 2.5 mg/dL; Coagulation function: International normalized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN, if the subject is receiving anticoagulant therapy, PT or PTT should be within the permissible range of the anticoagulant used; Prolonged corrected QT (QTc) interval > 475 ms on screening EKG [excluded]; Ejection fraction <40% on 2D echocardiogram (ECHO) at screening [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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