Status:
NOT_YET_RECRUITING
AG Combined With Immunotherapy and SBRT in Patients With Potentially Resectable Pancreatic Cancer
Lead Sponsor:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborating Sponsors:
The First Affiliated Hospital with Nanjing Medical University
Fudan University
Conditions:
Pancreatic Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
Due to the hidden onset and rapid progression of pancreatic cancer, most patients are already locally advanced or have distant metastasis at the time of diagnosis and lose the opportunity for surgery....
Eligibility Criteria
Inclusion
- Age \>= 18 years；
- Eastern Cooperative Oncology Group (ECOG) score of 0-1;
- Pancreatic cancer confirmed by histology or cytology;
- Potentially resectable pancreatic cancer documented by contrast enhanced CT (or MRI) scan;
- 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.
- 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;
- Signed informed consent;
- Follow the protocol and follow-up procedures.
Exclusion
- Have received systematic anti-tumor treatment.
- 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).
- Active bacterial or fungal infection (\> = level 2 of National Cancer Institute Common Toxicity Criteria (NCI-CTC), Version 3.0).
- 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.
- Autoimmune diseases or immune defects who are treated with immunosuppressive drugs.
- Pregnant and lactating women. Pregnant women of childbearing age must be tested negative within 7 days before entering the group.
- Drug abuse, clinical or psychological or social factors make informed consent or research implementation affected.
- Allergic to programmed cell death protein-1 (PD-1) monoclonal antibody immunotherapy drugs.
Key Trial Info
Start Date :
November 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 6 2026
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT06080854
Start Date
November 10 2023
End Date
June 6 2026
Last Update
October 12 2023
Active Locations (1)
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1
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China, 210008