To evaluate the efficacy of PD-L1/CTLA4 BsAb for the second line treatment and the combination with chemotherapy for the first line treatment in pancreatic cancer
Subjects who signed the informed consent were assigned to three cohorts according to the actual treatment status. Cohort 1 enrolled subjects receiving PD-L1/CTLA4 BsAb 5mg/kg iv Q2W for 2nd treatment; cohort 2 enrolled subjects receiving PD-L1/CTLA4 BsAb in combination with gemcitabine/albumin- paclitaxel as 1st treatment for 4-6 cycles with PD-L1/CTLA4 BsAb monotherapy maintainence; cohort 3 enrolled subjects received systemic chemotherapy, receiving PD-L1/CTLA4 BsAb combined with oxaliplatin / irinotecan / leucovorin / fluorouracil (FOLFIRINOX) as 1st treatment for 4-6 cycles withPD-L1/CTLA4 BsAb monotherapy maintainence; until disease progression according to RECIST 1.1, intolerable toxicity, withdrawal, death, 2-yr treatment,who comes first.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
PD-L1/CTLA4 BsAb 5mg/kg, iv,Q2W
Gemcitabine 1000mg/m2, iv, D1,8,15, 28days/cycle; nab-Paclitaxel 125mg/m2,iv,D1,8,15, 28days/cycle;
Fluorouracil 2400mg/m2,iv,D1, 14days/cycle; Oxaliplatin 68-85mg/m2,iv, D1,14days/cycle;Irinotecan135-180mg/m2,iv, D1, 14days/cycle;Calcium Folate 400mg/m2,iv, D1, 14days/cycle;
Changhai hospital
Shanghai, Shanghai Municipality, China
RECRUITINGORR
objective response rate
Time frame: 2 years
DCR
Disease Control Rate
Time frame: 2 years
DOR
Duration of Response
Time frame: 2 years
TTP
Time to Response
Time frame: 2 years
PFS
Progression Free Survival
Time frame: 2 years
OS
Overall Survival
Time frame: 2 years
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