Overview

Study of Immunotherapy Combined With Chemotherapy in Locally Advanced and Metastatic Pancreatic Cancer

Status:
Recruiting
Trial end date:
2023-11-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Changhai Hospital
Treatments:
Albumin-Bound Paclitaxel
Calcium
Fluorouracil
Folfirinox
Folic Acid
Gemcitabine
Irinotecan
Oxaliplatin
Paclitaxel
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,