Locally Advanced and Metastatic Pancreatic Cancer
Conditions
Brief summary
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
Detailed description
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.
Interventions
DRUGPD-L1/CTLA4 BsAb
PD-L1/CTLA4 BsAb 5mg/kg, iv，Q2W
COMBINATION_PRODUCTGP
Gemcitabine 1000mg/m2, iv, D1,8,15, 28days/cycle; nab-Paclitaxel 125mg/m2，iv，D1,8,15, 28days/cycle;
COMBINATION_PRODUCTFOLFIRINOX
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;
Sponsors
Changhai Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Histology or cytology confirmed as pancreatic ductal adenocarcinoma; * ECOG 0-1; * adequate organ function (absolute neutrophil count ≥1.5 x 109/L; platelet count ≥100 x 109/L; creatinine \< 1.5 x ULN (upper normal) or calculated creatinine clearance ( CRCI) ≥ 60mL/min; albumin ≥ 30g/L; total bilirubin \<1.5 x ULN; aspartate aminotransferase (AST) \< 2.5 x ULN; alanine aminotransferase (ALT) \< 2.5x ULN; INR or PT \< 1.5x ULN, and aPTT \<1.5x ULN); * no obvious symptoms of jaundice and ascites; * no other serious underlying diseases
Exclusion criteria
* patients with active brain metastases; * history of autoimmune diseases, or need to be treated with corticosteroids and immunosuppressive agents; * past history of unstable angina, symptomatic congestive heart failure, severe arrhythmia, myocardial infarction within 6 months, QT interval prolongation (\>450ms); * other malignant tumors within the last 5 years; * pregnant or lactating women; * NRS ≥ 4 points; * unintentional weight loss ≥ 5% within 1 month before the first dose even if peripheral or central vein nutrition support,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR | 2 years | objective response rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DCR | 2 years | Disease Control Rate |
| DOR | 2 years | Duration of Response |
| TTP | 2 years | Time to Response |
| PFS | 2 years | Progression Free Survival |
| OS | 2 years | Overall Survival |
Countries
China
Contacts
Primary ContactShiwei Guo, Doctor
Backup ContactSuizhi Gao, Doctor
Outcome results
None listed