The purpose of this study is to assess the safety and efficacy of AK104 plus concurrent chemoradiation therapy in unresectable locally advanced esophageal squamous cell carcinoma
AK104 10mg/kg plus TC regimen(paclitaxel liposome 135mg/m2, carboplatin AUC=5), once every 3 weeks (Q3W), induction treatment for 2 cycles; Subsequently, AK104 10 mg/kg plus TC regimen(paclitaxel liposome 135mg/m2, carboplatin AUC=5) is combined with radiotherapy(50Gy/25F) for 2 cycles. Assess disease efficiency( objective response rate; disease control rate; duration of overall response; time to resolve) and safety( adverse event).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
47
AK104 plus TC regimen(paclitaxel liposome , carboplatin), once every 3 weeks (Q3W), induction treatment for 2 cycles; Subsequently, AK104 plus TC regimen is combined with radiotherapy for 2 cycles.
ORR
objective response rate
Time frame: 24 months
DCR
disease control rate
Time frame: 24 months
DoR
duration of overall response
Time frame: 24 months
TTR
time to resolve
Time frame: 24 months
AE
adverse event
Time frame: 24 months
PFS
progression-free survival
Time frame: 24 months
OS
overall survival
Time frame: 24 months
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