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Trial Title:
AG Combined With Immunotherapy and SBRT in Patients With Potentially Resectable Pancreatic Cancer
NCT ID:
NCT06080854
Condition:
Pancreatic Carcinoma
Conditions: Official terms:
Pancreatic Neoplasms
Paclitaxel
Gemcitabine
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Toripalimab
Description:
Toripalimab 240mg administered intravenously on Days 1 of every 3 weeks
Arm group label:
Concurrent radiochemotherapy combined with immunotherapy
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
Gemcitabine 1000 mg/m^2 administered intravenously on Days 1 & 8 of every 3 weeks
Arm group label:
Concurrent radiochemotherapy combined with immunotherapy
Intervention type:
Drug
Intervention name:
Nab paclitaxel
Description:
Nab paclitaxel 125 mg/m^2 administered intravenously on Days 1 & 8 of every 3 weeks.
Arm group label:
Concurrent radiochemotherapy combined with immunotherapy
Intervention type:
Other
Intervention name:
SBRT
Description:
SBRT Radiotherapy plan: Planning gross tumor volume (PGTV) 5Gy*10 fractions, Planning
target volume (PTV) 3Gy*10 fractions
Arm group label:
Concurrent radiochemotherapy combined with immunotherapy
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. Even among operable patients, about 50% will have recurrence and
metastasis one year after surgery. Therefore, more and more evidence supports neoadjuvant
therapy for patients with high risk factors for resectable pancreatic cancer, and
conversion therapy followed by surgery for patients with borderline resectable and
locally advanced pancreatic cancer. Therefore, 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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Address:
City:
Nanjing
Zip:
210008
Country:
China
Start date:
November 10, 2023
Completion date:
June 6, 2026
Lead sponsor:
Agency:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital with Nanjing Medical University
Agency class:
Other
Collaborator:
Agency:
Fudan University
Agency class:
Other
Collaborator:
Agency:
Shanghai Changzheng Hospital
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Soochow University
Agency class:
Other
Collaborator:
Agency:
Xuzhou Central Hospital
Agency class:
Other
Source:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06080854
