Overview

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

Status:
Not yet recruiting
Trial end date:
2026-06-06
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborators:
Fudan University
Shanghai Changzheng Hospital
The First Affiliated Hospital of Soochow University
The First Affiliated Hospital with Nanjing Medical University
Xuzhou Central Hospital
Treatments:
Gemcitabine
Paclitaxel
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.