The 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Paclitaxel Polymeric Micelles for Injection:Cycle 1: 230mg/m2, IV ≥3 hours; Cycles 2-4: If the patient has a neutrophil nadir ≥1.0 x 109/L along with a platelet nadir ≥80 x 109/L after Cycle 1 dosing and has not experienced grade II-IV non-hematologic toxicity, then give 260mg/m2, IV ≥3 hours, d1, q3w; Cisplatin: 25mg/m2/d x d1-3, IV drip, q3w; Cadonilimab: 10mg/kg, IV drip, d3, q3w;
the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
RECRUITINGPathological complete response (pCR) rates
evaluate pathological complete response rate of primary tumor and locally metastatic lymph nodes after 2-4 cycles of neoadjuvant therapy.
Time frame: From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.
Objective Rate of Effectiveness (ORR)
the proportion of patients who achieve PR or CR
Time frame: From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.
R0 Removal Rate
Rate of microscopically margin-negative resection
Time frame: From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.
2-year overall survival rate
2-year overall survival rate
Time frame: 2 years
2-year disease free survival rate
2-year disease free survival rate
Time frame: 2 years
major pathological response (MPR)
Time frame: From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.
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