OncoMatch/Clinical Trials/NCT07105592
A Study of Nimotuzumab Plus Adebrelimab With Chemotherapy in Cisplatin-Ineligible Patients With Head And Neck Squamous Cell Carcinoma
Is NCT07105592 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Nimotuzumab+Adebrelimab+Chemotherapy for head and neck squamous cell carcinoma.
Treatment: Nimotuzumab+Adebrelimab+Chemotherapy — This is a prospective, single-arm, Phase Ib/II clinical study to evaluate the safety and efficacy of nimotuzumab combined with adebrelimab and chemotherapy in patients with recurrent and metastatic head and neck squamous cell carcinoma who are ineligible to high-dose cisplatin treatment.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) testing required; no eligibility threshold specified (testing required; no eligibility threshold specified)
Availability of tumor tissue (from the tumor core or resected tumor) for PD-L1 testing (if previously tested, additional testing is not required).
Required: CDKN2A testing required; no eligibility threshold specified (testing required; no eligibility threshold specified)
Availability of tumor tissue for P16/HPV testing (if previously tested, retesting is not required).
Disease stage
Metastatic disease required
recurrent or metastatic head and neck squamous cell carcinoma, meeting the following conditions: Local treatment methods cannot achieve a cure
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: systemic therapy (targeted therapy, immunotherapy, and/or chemotherapy)
Exception: No prior systemic treatment after recurrence or metastasis
No prior systemic treatment (targeted therapy, immunotherapy, and/or chemotherapy) after recurrence or metastasis.
Lab requirements
Blood counts
ANC: ≥1500/μL, Platelets: ≥100,000/μL, Hemoglobin: ≥9 g/dL
Kidney function
Serum Creatinine or Creatinine Clearance: Creatinine ≤1.5 × ULN; if creatinine >1.5 × ULN, then creatinine clearance must be ≥60 mL/min
Liver function
Total Bilirubin: ≤1.5 × ULN, AST and ALT: ≤2.5 × ULN; if liver metastases are present, then ≤5 × ULN
Adequate organ function：Hematology: ANC ≥1500/μL, Platelets ≥100,000/μL, Hemoglobin ≥9 g/dL. Renal: Creatinine ≤1.5 × ULN; if creatinine >1.5 × ULN, then creatinine clearance must be ≥60 mL/min. Hepatic: Total Bilirubin ≤1.5 × ULN, AST and ALT ≤2.5 × ULN; if liver metastases are present, then ≤5 × ULN. Coagulation: INR or PT ≤1.5 × ULN; if the patient is receiving anticoagulant therapy, PT or PTT must be within the therapeutic range for the anticoagulant used.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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