This is a prospective, single-arm, open-label,multi-center, phase II study, aiming to evaluate the efficacy and safety of AK104 combined with preoperative chemotherapy in patients with locally advanced ESCC.
Eligible patients first receive AK104 (10mg/kg, iv, Q2W) for one cycle in the induction period, and then patients receive AK104 (10mg/kg, iv, Q3W) combined with nab-paclitaxel (130mg/m2 ivgtt d1,d8, Q3W) and carboplatin ((AUC=5) d1,Q3W) for 2 cycles. After neoadjuvant therapy of 3 cycles, patient will undergo preoperative evaluation. For patients who can be performed for R0 surgery, surgery wil be performed in 4 to 6 weeks. Patients who do not achieve Pathological complete response (pCR) will receive AK104 (10mg/kg, iv, Q3W) as adjuvant therapy until disease progression or intolerable toxicity for up to 12 months. Patients who achieve pCR after surgery will be enrolled in observational follow-up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
AK104 plus nab-paclitaxel and carboplatin as neoadjuvant therapy,and AK104 as adjuvant therapy for those who do not achieve pCR;
Anyang Cancer Hospital
Anyang, Henan, China
Feng Wang
Zhengzhou, Henan, China
pCR
Pathological complete response
Time frame: up to 2 years
MPR
Major pathologic response
Time frame: up to 2 years
R0 resection rate
R0 resection rate
Time frame: up to 2 years
Downstaging rate
Downstaging rate
Time frame: up to 2 years
DFS
Disease-free survival
Time frame: up to 2 years
OS
Overall survival
Time frame: up to 2 years
AE
Adverse event
Time frame: up to 2 years
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