Pancreatic Carcinoma
Conditions
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. 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.
Interventions
DRUGToripalimab
Toripalimab 240mg administered intravenously on Days 1 of every 3 weeks
DRUGGemcitabine
Gemcitabine 1000 mg/m\^2 administered intravenously on Days 1 & 8 of every 3 weeks
DRUGNab paclitaxel
Nab paclitaxel 125 mg/m\^2 administered intravenously on Days 1 & 8 of every 3 weeks.
OTHERSBRT
SBRT Radiotherapy plan: Planning gross tumor volume (PGTV) 5Gy\*10 fractions, Planning target volume (PTV) 3Gy\*10 fractions
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Fudan University
Shanghai Changzheng Hospital
The First Affiliated Hospital of Soochow University
Xuzhou Central Hospital
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR | 2 years | RECIST Version 1.1 RECIST Version 1.1 RECIST Version 1.1 RECIST Version 1.1 RECIST Version 1.1 RECIST Version 1.1 |
| R0 resection rate | 2 years | R0 resection rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| os | 3 years | OS is defined as the time from randomization to death due to any cause. |
| pfs | 3 years | PFS is defined as the time from the first day of randomization to the date of first record of disease progression or death. |
| dcr | 3 years | DCR including CR, PR, and SD |
| Adverse Events | 3 years | Adverse event (AE)、Serious adverse event (SAE) |
Countries
China
Outcome results
None listed