Status:
UNKNOWN
Nab-Paclitaxel and Gemcitabine Plus Camrelizumab and Radiotherapy for Locally Advanced Pancreatic Adenocarcinoma
Lead Sponsor:
Sun Yat-sen University
Conditions:
PDAC - Pancreatic Ductal Adenocarcinoma
Eligibility:
All Genders
18-75 years
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-pacl...
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 datab...
Eligibility Criteria
Inclusion
- aged 18-75 years;
- histologically or cytologically proven diagnosis of pancreatic adenocarcinoma;
- treatment-naive locally advanced pancreatic cancer (locally advanced status was determined by our multidisciplinary team based on the National Comprehensive Cancer Network definitions);
- no distant metastasis as defined by CT or MRI of the chest, abdomen and pelvis;
- at least 1 measurable lesion based on the Response Evaluation Criteria in Solid Tumors criteria (RECIST) 1.1;
- an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1;
- adequate hematological, liver, renal function:
- absolute neutrophil count≥1500 cell/mm3;
- platelet count≥100×109/L;
- hemoglobin concentration \>90 g/L;
- albumin≥30 g/L ;
- total bilirubin\<1.5 times the upper limit of normal;
- alanine aminotransferase and aspartate aminotransferase≤3 times the upper limit of normal;
- serum creatinine concentration\<1.5 times the upper limit of the normal range or less and creatinine clearance rate≥45 mL/min;
- life expectancy of at least 3 months.
Exclusion
- with any other malignancy within the 5 years before enrolment;
- 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;
- with peripheral sensory neuropathy at a grade \>1;
- with a history of allergy or hypersensitivity to the study drugs;
- pregnant or breast feeding women, reproductive aged women who refused to take adequate contraceptive measures during the study.
Key Trial Info
Start Date :
April 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04365049
Start Date
April 1 2020
End Date
December 1 2023
Last Update
February 22 2023
Active Locations (1)
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1
Frist Affliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510080