OncoMatch/Clinical Trials/NCT06165380
Cardenilimab Combined With Chemotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma
Is NCT06165380 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Cardenilimab Combined With Chemotherapy for esophageal squamous cell carcinoma.
Treatment: Cardenilimab Combined With Chemotherapy — The goal of this trial is to test the efficacy and safety of cardenilimab combined with chemotherapy in the conversion therapy of locally advanced unresectable esophageal squamous cell carcinoma. type of study: clinical trial
Check if I qualifyExtracted eligibility criteria
Cancer type
Esophageal Carcinoma
Disease stage
Required: Stage NXM0 (8th edition of AJCC TNM)
diagnosed as cT4a, T4b, NXM0 according to the 8th edition of AJCC TNM staging, and assessed as initially unresectable by the surgeon
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic therapy
Have not received any systemic treatment for the current disease in the past, including surgery, anti-tumor radiotherapy, chemotherapy/immunotherapy, etc.
Cannot have received: anti-PD-1/PD-L1/PD-L2 or co-inhibitory T-cell receptor therapy
Have previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or another type of stimulating or synergistic inhibition of T cell receptors (including but not limited to CTLA-4, OX-40, CD137 etc.) drugs
Cannot have received: systemic Chinese patent medicines with anti-tumor indications or drugs with immunomodulatory effects (thymosin, interferon, interleukin)
Exception: except for local use to control pleural effusion
Have received systemic systemic treatment with Chinese patent medicines with anti-tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin, except for local use to control pleural effusion) within 2 weeks before the first dose
Lab requirements
Blood counts
ANC ≥1.5x10^9/L without G-CSF in past 14 days; platelets ≥100×10^9/L without transfusion in past 14 days; hemoglobin >9g/dL without transfusion or erythropoietin in past 14 days
Kidney function
Serum creatinine ≤1.5×ULN and creatinine clearance ≥60 ml/min
Liver function
Total bilirubin ≤1.5×ULN; AST and ALT ≤2.5×ULN
Cardiac function
Myocardial enzyme spectrum within normal range (unless judged not clinically significant); good coagulation function (INR or PT ≤1.5×ULN); euthyroid (TSH within normal range, or T3/FT3 and FT4 within normal range if TSH abnormal)
With sufficient organ function, subjects must meet the following laboratory indicators: 1. Absolute neutrophil count (ANC) ≥1.5x10^9/L without using granulocyte colony-stimulating factor in the past 14 days; 2. Without blood transfusion in the past 14 days, platelets ≥100×10^9/L; 3. Hemoglobin >9g/dL without blood transfusion or erythropoietin use in the past 14 days; 4. Total bilirubin ≤1.5×ULN; 5. AST and ALT ≤2.5×ULN; 6. Serum creatinine ≤1.5×ULN and creatinine clearance ≥60 ml/min; 7. Good coagulation function, defined as INR or PT ≤ 1.5×ULN; 8. Euthyroid, defined as TSH within the normal range. If baseline TSH is outside the normal range, subjects can also be enrolled if total T3 (or FT3) and FT4 are within the normal range; 9. Myocardial enzyme spectrum is within the normal range (if the researcher comprehensively judges that simple laboratory abnormalities without clinical significance are also allowed to be included)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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