This is a randomized, controlled, multi-center phase II/III study. All patients are resectable locally advanced thoracic esophageal squamous cell carcinoma (ESCC), Eastern Cooperative Oncology Group (ECOG) performance status 0-1. The purpose of this study is to evaluate the efficacy and safety of perioperative Cadonilimab combined with neoadjuvant chemotherapy versus neoadjuvant chemotherapy in patients with resectable ESCC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Specified doses on specified days.
IV infusion; 75mg/m2
IV infusion; 175mg/m2
The Second Affiliated Hospital of Air Force Medical University
Xi'an, China
RECRUITINGPathologic Complete Response (pCR) rate as assessed by the investigator
Proportion of subjects with no tumor residue in the primary tumor and regional lymph nodes.
Time frame: Up to approximately 2 years
Adverse Event (Phase II stage)
Incidence and severity of adverse events (AEs), rate of delayed surgery, and clinically significant abnormal laboratory findings.
Time frame: Up to approximately 5 years
Major Pathological Response (MPR) rate as assessed by the investigator
Proportion of subjects with ≤10% residual live tumor cells as assessed by the investigator.
Time frame: Up to approximately 2 years
R0 resection rate
Proportion of subjects with pathologically complete resection of primary tumors
Time frame: Up to approximately 2 years
Event Free Survival (EFS)
Time from randomization until radiographic disease progression, local progression precluding surgery, inability to resect the tumor, local or distant recurrence, or death due to any cause.
Time frame: Up to approximately 5 years
Disease Free Survival (DFS)
Time from surgery to local or distant recurrence, or death due to any cause.
Time frame: Up to approximately 5 years
Overall Survival (OS)
Time from randomization until death from any cause.
Time frame: Up to approximately 5 years
Overall Response Rate (ORR)
Proportion of subjects with complete response (CR) or partial response (PR) during the neoadjuvant stage.
Time frame: Up to approximately 2 years
Disease Control Rate (DCR)
Evaluation of DCR based on RECIST v1.1
Time frame: Up to approximately 2 years
Pharmacokinetics (PK)
PK parameters: serum concentrations of Cadonilimab at different point of time
Time frame: Up to approximately 2 years
Anti-Drug Antibodies(ADAs)
Proportion of subjects with detectable ADA.
Time frame: Up to approximately 2 years
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