This is a two-arm, open, multicenter clinical study to evaluate the efficacy and safety of AK104 alone or in combination with cisplatin and paclitaxel in the treatment of advanced esophageal squamous carcinoma without systemic therapy.
During the treatment, eligible patients in cohort A with PD-L1 CPS ≥5 will receive AK104 10 mg/kg, intravenously, every 3 weeks (maximum 24 months of dosing); in cohort B, regardless of PD-L1 expression, eligible patients will receive AK104 10 mg/kg, intravenously, every 3 weeks (maximum 24 months of dosing), in combination with cisplatin (75 mg/m2) and paclitaxel (175 mg/m2), Q3W (up to 6 cycles, the specific cycles will be determined by the investigator). Thereafter, AK104 maintenance therapy will be continued until disease progression, intolerable toxicity, withdrawal of informed consent, death, or end of the study, whichever occurred first (maximum duration of treatment with AK104 should be less than 12 months). When patients with initially unresectable disease transformed into resectable, an operation can be considered and the original regimen may be used after surgery.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
10mg/kg IV every 3 weeks (Q3W)
75mg/m2 IV every 3 weeks (Q3W)
175mg/m2 IV every 3 weeks (Q3W)
Objective response rate (ORR)
ORR is proportion of subjects with complete response(CR) or partial response(PR), based on Response Evaluation Criteria in Solid Tumors(RECIST) v1.1.
Time frame: Up to approximately 2 years
Progression-free survival (PFS)
Progression-free survival (PFS) is defined as the time from the first dose of investigational products until documentation of PD (as per RECIST v1.1) or death due to any cause, whichever occurs first.
Time frame: Up to approximately 2 years
Overall survival (OS)
Overall survival (OS) is defined as the time from the first dose of investigational products until death due to any cause.
Time frame: Up to approximately 2 years
Disease control rate (DCR)
Disease control rate (DCR) is defined as the proportion of subjects achieving a best of response(BOR) of confirmed CR and PR and stable disease(SD) per RECIST v1.1.
Time frame: Up to approximately 2 years
Duration of response (DoR)
Duration of response (DoR) is defined as the period from the first documentation of confirmed response (CR or PR) to the first documentation of progressive disease(PD) (as per RECIST v1.1) or death due to any cause, whichever occurs first.
Time frame: Up to approximately 2 years
Incidence and severity of adverse events(AEs)
Incidence and severity of AEs is aim to evaluate the safety of AK104 alone or combination with chemotherapy.
Time frame: Up to approximately 2 years
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