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OncoMatch/Clinical Trials/NCT06356688

A Clinical Study on the Efficacy and Safety of Paclitaxel Polymeric Micelles and Cisplatin Combined With Cadonilimab as a Neoadjuvant Therapy for Locally Advanced Esophageal Squamous Cell Carcinoma

Is NCT06356688 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Paclitaxel Polymeric Micelles for for locally advanced esophageal squamous cell carcinoma.

Phase 2RecruitingSun JingNCT06356688Data as of May 2026

Treatment: Paclitaxel Polymeric Micelles forThe purpose of this study is to investigate the efficacy and safety of neoadjuvant treatment of locally advanced esophageal squamous carcinoma with a PD-1/CTLA-4 bispecific antibody (Cadonilimab) in combination with platinum-containing chemotherapy (Paclitaxel Polymeric Micelles for Injection combined with Cisplatin). Includes pathologic complete remission rates (pCR rates) after 2-4 cycles of Cadonilimab combination chemotherapy. The objective remission rate (ORR), major pathologic remission rate (MPR), R0 resection rate and 2-year overall survival (OS) and progression-free survival (OS) rates, and safety of neoadjuvant treatment of locally advanced esophageal squamous carcinoma with Cadonilimab combined with chemotherapy.

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Extracted eligibility criteria

Cancer type

Esophageal Carcinoma

Disease stage

Required: Stage CT2-4AN+, CT3-4AN0, II, III, IVA (AJCC 8th edition cTNM)

Locally advanced patients with no distant metastasis by imaging, resectable or potentially resectable...clinical stage cT2-4aN+ or cT3-4aN0, M0, stage II, III, or IVA (AJCC 8th edition cTNM staging)

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: chemotherapy

No previous antitumor treatment such as radiotherapy, chemotherapy and immunotherapy

Cannot have received: radiotherapy

No previous antitumor treatment such as radiotherapy, chemotherapy and immunotherapy

Cannot have received: immunotherapy

No previous antitumor treatment such as radiotherapy, chemotherapy and immunotherapy

Cannot have received: surgery

Patients who have previously received anti-tumor therapy (including chemotherapy, radiotherapy, surgery or immunotherapy, etc.)

Lab requirements

Blood counts

WBC ≥3×10^9/L, ANC ≥1.5×10^9/L, PLT ≥100×10^9/L, Hb ≥9g/dL

Kidney function

cCr>40 ml/min, Cr≤1.5 ULN

Liver function

TBIL ≤2ULN, AST ≤2.5ULN, ALT ≤2.5ULN

Cardiac function

no cardiac disease or coronary artery disease, cardiac function grade 1-2

Adequate baseline organ function: (i) WBC ≥3×10^9/L, ANC ≥1.5×10^9/L, PLT ≥100×10^9/L, Hb ≥9g/dL; (ii) Liver function: TBIL ≤2ULN, AST ≤2.5ULN, ALT ≤2.5ULN; (iii) Renal function: cCr>40 ml/min, Cr≤1.5 ULN; (iv) Cardiac function: no cardiac disease or coronary artery disease. Cardiac function: no heart disease or coronary heart disease, patients with cardiac function grade 1-2;

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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