This is a multicenter, open-label, randomized, controlled clinical study to compare the efficacy and safety of cardonilizumab combined with neoadjuvant chemotherapy and surgery versus neoadjuvant chemoradiotherapy and surgery in locally advanced ESCC. Subjects were randomly divided into experimental group and control group, the experimental group received neoadjuvant immunotherapy concurrent chemotherapy regimen, the control group received neoadjuvant concurrent chemoradiotherapy regimen, and then received McKeown surgery. The primary outcome measures were complete pathological response (pCR), and the secondary outcome measures were major pathological response (MPR), EFS (event-free survival), OS (overall survival), overall response rate (ORR), decreased pathological stage, R0 resection rate, adverse events (AE), and perioperative complications
Sign a written informed consent before implementing any procedures related to the trial;
Male or female, 18 years old ≤75 years old;
Patients with histologically proven ESCC with a pathological stage of cT1N2M0 or cT2-3N0-2M0 according to AJCC Version 8 TNM stage and eligible for R0 surgical resection prior to treatment;
Have not received systematic treatment for the current disease, including surgical treatment, anti-tumor chemoradiotherapy/immunotherapy, etc.;
Diagnosis of other malignant diseases (excluding radical basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or carcinoma in situ after radical resection) within 1.5 years;
Known endoscopic signs of active bleeding;
Is currently participating in an interventional clinical study, or has received other investigational drugs or used investigational devices within 4 weeks prior to initial dosing;
Previous treatment with anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that respond to another stimulus or synergistic inhibition of T cell receptors (including but not limited to CTLA-4, OX-40, CD137, etc.);
Parallel
Cardonilizumab
Biological/VaccineCardonilizumab 10 mg/kg, once every 3 weeks, will be administered intravenously as an infusion of 120 minutes (±10 minutes). The investigator continuously monitors potential infusion responses and pretreats hypersensitivity reactions and/or adjusts the infusion rate as recommended by the protocol. For subjects who cannot tolerate a 120-minute infusion, the infusion time can be extended to a maximum of 240 minutes. Within 72 hours prior to each dosing, subjects were required to complete a series of tests including vital signs, physical examination, laboratory tests, and fitness status scores to assess the safety and tolerability of continued treatment
Paclitaxel
Drugpaclitaxel 135mg/m2, intravenous infusion on day 2, once /3 weeks, 3 consecutive cycles before surgery
Cisplatin
DrugCisplatin 80mg/m2, intravenous infusion on day 2, once /3 weeks, 3 consecutive cycles before surgery
neoadjuvant chemoradiotherapy
RadiationRadiotherapy: 40 Gy (2Gy×20 times), 5 times/week for 5 consecutive weeks; Chemotherapy: paclitaxel 50mg/m2+ cisplatin 25mg/m2 once a week for 4 weeks
Pathologic Complete Response Rate
Percentage of participants with pathologic complete response, defined as no viable tumor cells in all resected tumor specimens and sampled regional lymph nodes after neoadjuvant treatment.
Major Pathologic Response Rate
Percentage of participants with major pathologic response, defined as 10% or less residual viable tumor cells in the resected tumor specimens after neoadjuvant treatment.
Event-Free Survival
Time from randomization to disease progression precluding surgery, local recurrence, distant metastasis, or death from any cause, whichever occurs first.
Overall Survival
Time from randomization to death from any cause.
Objective Response Rate Assessed by RECIST v1.1
Percentage of participants with complete response or partial response according to Response Evaluation Criteria in Solid Tumors version 1.1.
Click on the lead sponsor to view all of their trials.
