PDAC - Pancreatic Ductal Adenocarcinoma
Conditions
Brief summary
The study is a prospective and observational cohort study. The purpose is to to investigate the safety and efficacy of nab-paclitaxel and gemcitabine plus camrelizumab and radiotherapy versus nab-paclitaxel and gemcitabine alone for locally advanced pancreatic adenocarcinoma (PDAC)
Detailed description
We will prospectively collect 100 patients who receive nab-paclitaxel and gemcitabine plus camrelizumab and radiotherapy or nab-paclitaxel and gemcitabine alone. Data will be stored in a private database. The process of data collection will be supervised and regular data examination will be performed.
Interventions
RADIATIONRadiotherapy
Radiotherapy started after two cycles of chemotherapy. External beam radiation therapy was performed using an intensity modulated radiation therapy technique. The gross target volume included the gross primary tumor and positive regional lymph nodes as defined by the multiphasic imaging. A total radiation dose greater than 50 Gy without damaging organ function was the essential requirement.
DRUGNab-paclitaxel
Eight 21-day cycles of nab-paclitaxel 125 mg/m² by intravenous infusion for approximately 30-45 mins on days 1 and 8.
DRUGGemcitabine
Eight 21-day cycles of gemcitabine 1000mg/m² intravenous infusion for approximately 30 mins on days 1 and 8.
DRUGCamrelizumab
Anti-PD-1 antibody (camrelizumab, Hengrui Medicine Co., Ltd) 200 mg was administered intravenously for 30 mins every three weeks. During the chemotherapy-treated period, camrelizumab was administered on day 1 of each 21-day cycle before the infusion of chemotherapy.
Sponsors
Sun Yat-sen University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. aged 18-75 years; 2. histologically or cytologically proven diagnosis of pancreatic adenocarcinoma; 3. treatment-naive locally advanced pancreatic cancer (locally advanced status was determined by our multidisciplinary team based on the National Comprehensive Cancer Network definitions); 4. no distant metastasis as defined by CT or MRI of the chest, abdomen and pelvis; 5. at least 1 measurable lesion based on the Response Evaluation Criteria in Solid Tumors criteria (RECIST) 1.1; 6. an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; 7. adequate hematological, liver, renal function: 1. absolute neutrophil count≥1500 cell/mm3; 2. platelet count≥100×109/L; 3. hemoglobin concentration \>90 g/L; 4. albumin≥30 g/L ; 5. total bilirubin\<1.5 times the upper limit of normal; 6. alanine aminotransferase and aspartate aminotransferase≤3 times the upper limit of normal; 7. serum creatinine concentration\<1.5 times the upper limit of the normal range or less and creatinine clearance rate≥45 mL/min; 8. life expectancy of at least 3 months.
Exclusion criteria
1. with any other malignancy within the 5 years before enrolment; 2. with active infections (bacterial, viral, or fungal) requiring systematic treatment, with hepatitis B or C infection, or a history of HIV infection, or receiving immunosuppressive therapy; 3. with peripheral sensory neuropathy at a grade \>1; 4. with a history of allergy or hypersensitivity to the study drugs; 5. pregnant or breast feeding women, reproductive aged women who refused to take adequate contraceptive measures during the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | two years | defined as the time from randomization until disease progression or death from any cause, whichever happens first. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive and progression free. Patients not having an event will be censored at the date last seen alive. |
| Overall survival | two years | defined as the time from randomization until death from any cause. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive. Patients remaining alive throughout the duration of the study will have their survival time censored on the date last seen alive. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | two years | adverse events during the treatment period using Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0). |
| Tumor response | two years | measured according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1 by means of computed tomography (CT) or magnetic resonance imaging (MRI) at each follow-up. |
Countries
China
Contacts
Primary ContactMing Kuang, PhD
Backup ContactZhenwei Peng, PhD
Outcome results
None listed