OncoMatch/Clinical Trials/NCT05964101
Nivolumab Combined With Chemotherapy in the Treatment of Primary Tracheal Squamous Cell Carcinoma
Is NCT05964101 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Nivolumab for neoplasms.
Treatment: Nivolumab — This is a single-arm, open, II phase study to evaluate the safety and efficacy of Nivolumab + carboplatin + paclitaxel in 25 newly diagnosed patients with primary tracheal squamous cell carcinoma.
Check if I qualifyExtracted eligibility criteria
Disease stage
Required: Stage III
Excluded: Stage IV
chest CT is evaluated as early or locally advanced tracheal malignant tumor, and radical surgery is expected to be feasible or after neoadjuvant therapy. PET-CT confirmed no metastasis
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chinese herbal medicine used to control cancer
Lab requirements
Blood counts
ANC ≥ 1.5 × 10^9/L, platelet ≥ 100 × 10^9/L, hemoglobin ≥ 90g/L (no transfusion or growth factor support within 14 days before screening), INR or PT ≤ 1.5 × ULN
Kidney function
Good function of kidney; APTT ≤ 1.5 × ULN
Liver function
serum total bilirubin ≤ 1.5 × ULN (Gilbert syndrome patients < 3×ULN); AST and ALT ≤ 2.5 × ULN, or ≤ 5 × ULN with liver metastasis
Good function of other major organs (liver, kidney, blood system, etc.):-absolute neutrophil count ((ANC) ≥ 1.5 × 10^9), platelet (≥ 100 × 10^9), hemoglobin (≥ 90g/L). Note: patients shall not receive blood transfusion or growth factor support within 14 days before blood collection during the screening period;-International standardized ratio (INR) or prothrombin time (PT) ≤ 1.5 × normal upper limit (ULN);-activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;- serum total bilirubin ≤ 1.5 × ULN (Gilbert syndrome patients with total bilirubin must be < 3×ULN). Fertile female patients with aspartate and alanine aminotransferase (AST and ALT) ≤ 2.5 × ULN, or liver metastasis with AST and ALT ≤ 5 × ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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