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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
336
Cardonilizumab 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 135mg/m2, intravenous infusion on day 2, once /3 weeks, 3 consecutive cycles before surgery
Cisplatin 80mg/m2, intravenous infusion on day 2, once /3 weeks, 3 consecutive cycles before surgery
Radiotherapy: 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
Tongji hospital
Wuhan, Hubei, China
RECRUITINGPathologic 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.
Time frame: At surgery, after completion of 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.
Time frame: At the time of pathological assessment after surgery
Event-Free Survival
Time from randomization to disease progression precluding surgery, local recurrence, distant metastasis, or death from any cause, whichever occurs first.
Time frame: From randomization up to 5 years
Overall Survival
Time from randomization to death from any cause.
Time frame: From randomization up to 5 years
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.
Time frame: From baseline to preoperative tumor assessment after neoadjuvant treatment
Pathologic Downstaging Rate Based on TNM Staging
Percentage of participants with a decrease in pathological TNM stage after neoadjuvant treatment compared with baseline clinical TNM stage.
Time frame: At the time of pathological assessment after surgery
R0 Resection Rate
Percentage of participants who undergo microscopically margin-negative resection.
Time frame: At surgery
Number of Participants With Adverse Events Assessed by CTCAE v5.0
Number of participants with adverse events graded according to the Common Terminology Criteria for Adverse Events version 5.0.
Time frame: From informed consent to the end of safety follow-up
Number of Participants With Perioperative Complications Assessed by Clavien-Dindo Classification
Number of participants with perioperative complications graded according to the Clavien-Dindo classification.
Time frame: From surgery to 30 days after surgery
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