AG Combined With Immunotherapy and SBRT in Patients With Potentially Resectable Pancreatic Cancer

Launched by THE AFFILIATED NANJING DRUM TOWER HOSPITAL OF NANJING UNIVERSITY MEDICAL SCHOOL · Oct 6, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment approach for patients with pancreatic cancer that may still be operable. The study aims to see how effective and safe it is to combine a type of chemotherapy and radiation therapy with immunotherapy, which helps the body’s immune system fight cancer. The trial is currently not recruiting participants, but it is designed for adults aged 18 and older who have been diagnosed with pancreatic cancer confirmed by tests and have imaging results showing that their cancer can potentially be removed by surgery.

To be part of this study, participants must have a good performance status, meaning they are able to carry out daily activities, and meet certain health criteria, including specific blood test results. Those who have had prior cancer treatments, certain infections, or specific health conditions may not be eligible. Participants will need to give their informed consent, follow study guidelines, and attend regular follow-up appointments. This trial represents a hopeful step towards finding better treatments for pancreatic cancer, which is known to be challenging to treat.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Age \>= 18 years；
• • 2. Eastern Cooperative Oncology Group (ECOG) score of 0-1;
• • 3. Pancreatic cancer confirmed by histology or cytology;
• • 4. Potentially resectable pancreatic cancer documented by contrast enhanced CT (or MRI) scan;
• • 5. Hematological indexes: Neutrophil count \>= 1.5 x 10\^9/L Hemoglobin \>= 10g / dl Platelet count \>= 100 x 10\^9/L; Biochemical indicators: Total bilirubin \<= 1.5 x upper limit of normal value (ULN); Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) \< 1.5 x ULN; Creatinine clearance rate \>= 60ml / min.
• • 6. Participants of childbearing age need to take appropriate protective measures (contraceptive measures or other methods of birth control) before entering the group and during the test;
• • 7. Signed informed consent;
• • 8. Follow the protocol and follow-up procedures.
• Exclusion Criteria:
• • 1. Have received systematic anti-tumor treatment.
• • 2. Previous history of other tumors, except for cervical cancer in situ, treated squamous cell carcinoma or bladder epithelial tumor (TA and TIS) or other malignant tumors that have received radical treatment (at least 5 years before enrollment).
• • 3. Active bacterial or fungal infection (\> = level 2 of National Cancer Institute Common Toxicity Criteria (NCI-CTC), Version 3.0).
• • 4. Human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B virus (HBV) infection, uncontrollable coronary artery disease or asthma, uncontrollable cerebrovascular disease or other diseases considered by researchers to be out of the group.
• • 5. Autoimmune diseases or immune defects who are treated with immunosuppressive drugs.
• • 6. Pregnant and lactating women. Pregnant women of childbearing age must be tested negative within 7 days before entering the group.
• • 7. Drug abuse, clinical or psychological or social factors make informed consent or research implementation affected.
• • 8. Allergic to programmed cell death protein-1 (PD-1) monoclonal antibody immunotherapy drugs.