Clinical trial NCT04324307: Study of Immunotherapy Combined With Chemotherapy in Locally Advanced and Metastatic Pancreatic Cancer
Official title: Multicenter, Open-label Clinical Study of PD-L1/CTLA4 BsAb Combined With Chemotherapy in Locally Advanced and Metastatic Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Locally Advanced and Metastatic Pancreatic Cancer
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2020-03-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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,

Primary outcomes:
measure: ORR
timeFrame: 2 years
Secondary outcomes:
measure: DCR
timeFrame: 2 years
measure: DOR
timeFrame: 2 years
measure: TTP
timeFrame: 2 years
measure: PFS
timeFrame: 2 years
measure: OS
timeFrame: 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai hospital
state: Shanghai
Study officials:
affiliation: Changhai Hospital
name: Gang Jin, Doctor
role: PRINCIPAL_INVESTIGATOR
References: