Last updated: August 31, 2023
Sponsor: Changhai Hospital
Overall Status: Active - Recruiting
Phase
1/2
Condition
Digestive System Neoplasms
Treatment
PD-L1/CTLA4 BsAb
FOLFIRINOX
GP
Clinical Study ID
NCT04324307
ChanghaiH-PP05
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
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; aspartateaminotransferase (AST) < 2.5 x ULN; alanine aminotransferase (ALT) < 2.5x ULN; INR orPT < 1.5x ULN, and aPTT <1.5x ULN);
- no obvious symptoms of jaundice and ascites;
- no other serious underlying diseases
Exclusion
Exclusion Criteria:
- patients with active brain metastases;
- history of autoimmune diseases, or need to be treated with corticosteroids andimmunosuppressive agents;
- past history of unstable angina, symptomatic congestive heart failure, severearrhythmia, 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 peripheralor central vein nutrition support,
Study Design
Total Participants: 60
Treatment Group(s): 3
Primary Treatment: PD-L1/CTLA4 BsAb
Phase: 1/2
Study Start date:
November 26, 2019
Estimated Completion Date:
November 30, 2023
Study Description
Connect with a study center
Changhai hospital
Shanghai, Shanghai 200433
ChinaActive - Recruiting
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