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

Trial ID: NCT06080854

Interventional - Phase 2 - Unknown status

The objective of this study is to evaluate the efficacy and safety of concurrent chemoradiotherapy combined with immunotherapy in patients with potentially resectable pancreatic cancer.

Conditions

• Pancreatic Carcinoma

Interventions

• Toripalimab
• Gemcitabine
• Nab paclitaxel
• SBRT

Eligibility

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.

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The First Affiliated Hospital with Nanjing Medical University, Fudan University, Shanghai Changzheng Hospital, The First Affiliated Hospital of Soochow University, Xuzhou Central Hospital

Source: ClinicalTrials.gov

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