Actively Recruiting
Adebrelimab in Combination With NALIRIFOX in Locally Advanced Pancreatic Cancer
Led by Fudan University · Updated on 2024-08-09
87
Participants Needed
1
Research Sites
77 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In this study, Adebrelimab combined with NALIRIFOX conversion therapy was performed in subjects with locally advanced pancreatic cancer to evaluate the efficacy and safety of conversion therapy with immunotherapy combined with chemotherapy, followed by different treatment methods such as surgery, continued conversion therapy, and advanced systemic therapy according to different transformation outcomes, to improve the survival benefit of subjects with locally advanced pancreatic cancer.
CONDITIONS
Official Title
Adebrelimab in Combination With NALIRIFOX in Locally Advanced Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years old
- Histologically or cytologically confirmed pancreatic ductal adenocarcinoma, preferably histologically confirmed
- Locally advanced pancreatic cancer judged unresectable by the investigator
- Total bilirubin level less than or equal to 2 mg/dL (including patients with bile duct stents if bilirubin 60 2 mg/dL and no cholangitis)
- No prior treatment for pancreatic cancer including surgery, chemotherapy, or radiotherapy
- At least one measurable lesion according to RECIST 1.1 criteria
- ECOG performance status score of 0 or 1 within 28 days before first dose
- Adequate organ function as shown by blood counts, liver, kidney, and coagulation tests
- Male participants and females of childbearing potential must use contraception from the first dose until 3 months after last dose
You will not qualify if you...
- Presence of distant metastases confirmed by imaging or histology
- Contraindications to surgical resection of pancreatic cancer
- Active autoimmune diseases or need for systemic glucocorticoids (>10 mg/day prednisone) within 14 days prior to first dose
- Use of immunosuppressive drugs within 14 days prior to first dose
- Prior treatment with tumor vaccines or immune-activating antitumor drugs within 1 month before first dose
- Participation in other clinical trials or receipt of investigational drugs within 4 weeks prior to first dose
- Other malignancies requiring treatment
- Significant prior cardiovascular disease
- History of allogeneic organ or hematopoietic stem cell transplantation
- Positive HIV serology
- Active hepatitis B or C infection requiring antiviral therapy
- Allergies or hypersensitivity to monoclonal antibodies, leucovorin, 5-FU, irinotecan, or oxaliplatin
- Any disease or abnormal lab result that may affect study results or participant safety as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, China, 200032
Actively Recruiting
Research Team
S
Si Shi, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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