This is a prospective, single-arm, open-label,single-center, phase II study, aiming to to evaluate the surgical conversion feasibility of AK104 combined with apatinib, paclitaxel and S-1 in unresectable stage IV G/GEJ cancer.
Eligible patients receive AK104 (10mg/kg, iv, Q3W) combined with apatinib (250mg, po, qd), paclitaxel (non-peritoneal metastasis: 130mg/m2, iv, D1; peritoneal metastasis :90mg/m2, iv, 40mg/m2, ip, D1) and S-1(60mg, po, bid, D1-D14) for up to 6 cycles. Patients assessed by Multi-Disciplinary Treatment (MDT) to meet the criteria for surgical resection undergo gastrectomy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Subjects will receive AK104 until disease progression or for up to 6 cycles.
Subjects will receive apatinib until disease progression or for up to 6 cycles.
Subjects will receive paclitaxel until disease progression or for up to 6 cycles.
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China
RECRUITINGR0 surgical conversion rate
Time frame: up to 2 years
R0 resection rate
Time frame: up to 2 years
Pathological complete response (pCR)
Time frame: up to 2 years
Pathological major response (MPR)
Time frame: up to 2 years
Objective response rate (ORR)
Time frame: up to 2 years
Disease control rate (DCR)
Time frame: up to 2 years
Progression-free survival (PFS)
Time frame: up to 2 years
Adverse event (AE)
Time frame: up to 2 years
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Subjects will receive S-1 until disease progression or for up to 6 cycles.