Actively Recruiting
Adebelimab Combined With Irinotecan Liposomal Injection, Oxaliplatin, Fluorouracil and Calcium Folinate Are Used in the First-line Treatment of Pancreatic Cancer Liver Metastasis Efficacy and Safety
Led by Jiang Long · Updated on 2024-07-31
40
Participants Needed
1
Research Sites
128 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
1. Evaluation of adebelimab in combination with irinotecan liposomes, oxaliplatin, fluorouracil, efficacy and safety of leucovorin in the first-line treatment of advanced metastatic pancreatic cancer 2. Construct the model of immunotherapy combined with chemotherapy for the treatment of pancreatic cancer liver metastasis
CONDITIONS
Official Title
Adebelimab Combined With Irinotecan Liposomal Injection, Oxaliplatin, Fluorouracil and Calcium Folinate Are Used in the First-line Treatment of Pancreatic Cancer Liver Metastasis Efficacy and Safety
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients voluntarily agree to participate and sign informed consent
- Age between 18 and 75 years inclusive, any gender
- Histologically confirmed pancreatic cancer with liver metastases and no prior systemic anti-tumor treatment
- No metastases in the central nervous system
- No adjuvant therapy within 6 months before enrollment
- ECOG performance status of 0 or 1
- Estimated survival of at least 12 weeks
- Normal major organ function as shown by blood tests within 7 days before treatment start, including: (1) Blood counts: Hemoglobin ≥ 90 g/L, Absolute neutrophil count ≥ 1.5 x10^9/L, Platelets ≥ 80 x10^9/L, no blood transfusions or granulocyte colony-stimulating factor within 14 days (2) Blood biochemistry: Total bilirubin ≤ 1.5 times upper limit of normal, ALT and AST < 2.5 times upper limit of normal (or < 5 times if liver metastasis present), creatinine ≤ 1 times upper limit of normal or creatinine clearance > 50 ml/min (3) Coagulation: INR ≤ 2.3 or prothrombin time within 6 seconds above normal (4) Urine protein less than 2+ or 24-hour urine protein less than 1.0 g if proteinuria present
- Women of childbearing potential must have a negative pregnancy test within 7 days before enrollment and agree to use contraception during the study and for 8 weeks after the last dose
- Men must be surgically sterile or agree to use contraception during the study and for 8 weeks after the last dose
- Ability and willingness to comply with study follow-up and adverse event reporting
You will not qualify if you...
- Presence of other active cancers within 5 years or simultaneously
- Uncontrolled heart conditions including: (1) NYHA class II or higher heart failure or left ventricular ejection fraction below 50% (2) Unstable angina (3) Myocardial infarction within 1 year before study start (4) Serious arrhythmias needing treatment (5) QTc interval > 450 ms for males or > 470 ms for females
- High blood pressure not controlled to below 140/90 mmHg by medication
- Blood clotting disorders (INR > 1.5 times normal, APTT > 1.5 times normal) or bleeding tendency
- Active bleeding
- Uncontrolled infections, chronic infections, or immune deficiency
- Known active hepatitis B infection
- Active or history of autoimmune disease with possible relapse
- Known severe allergy to study drugs
- Uncontrolled infection at screening
- Any other condition deemed unsuitable by the treating physician
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai General Hospital
Shanghai, Shanghai Municipality, China, 200040
Actively Recruiting
Research Team
L
Long Jiang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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