OncoMatch/Clinical Trials/NCT07070479
Combination Therapy for PD-1 Resistant Recurrent or Metastatic Nasopharyngeal Carcinoma: A Bayesian Adaptive Phase II Trial
Is NCT07070479 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for recurrent or metastatic nasopharyngeal carcinoma.
Treatment: Ivonescimab · Nimotuzumab · Irinotecan liposome · S-1 · Mitoxantrone Hydrochloride Liposome · PD-1 Inhibitors — This is a prospective, Bayesian adaptive, phase II clinical trial designed to evaluate the safety and efficacy of four treatment regimens in patients with recurrent (unamenable to local therapy) or metastatic nasopharyngeal carcinoma (NPC) who have failed after at least one prior platinum-containing standard regimen and anti-PD-1/PD-L1 therapy. The four treatment arms include: 1. Ivonescimab monotherapy, 2. Ivonescimab combined with nimotuzumab, 3. Liposomal mitoxantrone plus anti-PD-1 antibody, and 4. Liposomal irinotecan plus S-1.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy — doublet
Disease progression after prior platinum-based doublet chemotherapy
Must have received: anti-PD-1 therapy
Resistance to anti-PD-1 antibody therapy (either combination or sequential), including primary or secondary resistance（PD-1 exposure must be at least 6 weeks.）
Cannot have received: VEGF/VEGFR pathway inhibitor
Prior use of agents targeting the VEGF or VEGFR pathway
Cannot have received: any regimen included in the study protocol
Prior treatment with any regimen included in the study protocol
Lab requirements
Blood counts
WBC ≥ 4000/μL, absolute neutrophil count ≥ 2000/μL, hemoglobin ≥ 9 g/dL, platelets ≥ 100,000/μL
Kidney function
Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60 mL/min; proteinuria: UPC < 1.0; for UPC > 0.5, 24-hour urine protein < 1000 mg
Liver function
Total bilirubin ≤ 1.5 × ULN (Gilbert's syndrome ≤ 3 × ULN); AST and ALT ≤ 3 × ULN; alkaline phosphatase ≤ 3 × ULN; albumin ≥ 3 g/dL
Adequate organ function: Hematology: WBC ≥ 4000/μL, absolute neutrophil count ≥ 2000/μL, hemoglobin ≥ 9 g/dL, platelets ≥ 100,000/μL. Liver function: Total bilirubin ≤ 1.5 × ULN (patients with Gilbert's syndrome and bilirubin ≤ 3 × ULN are eligible); AST and ALT ≤ 3 × ULN; alkaline phosphatase ≤ 3 × ULN; albumin ≥ 3 g/dL. Coagulation: INR, PT, or aPTT ≤ 1.5 × ULN. Renal function: Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60 mL/min calculated by Cockcroft-Gault formula. Proteinuria: UPC < 1.0. For UPC ≤ 0.5, no further testing is required; for UPC > 0.5, 24-hour urine protein must be < 1000 mg for eligibility.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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