Clinical trial NCT04365049: Nab-Paclitaxel and Gemcitabine Plus Camrelizumab and Radiotherapy for Locally Advanced Pancreatic Adenocarcinoma
Official title: Nab-Paclitaxel and Gemcitabine Plus Camrelizumab and Radiotherapy Versus Nab-Paclitaxel and Gemcitabine Alone for Locally Advanced Pancreatic Adenocarcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: PDAC - Pancreatic Ductal Adenocarcinoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-04-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Advanced Pancreatic Adenocarcinoma

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Progression-free survival
timeFrame: two years
measure: Overall survival
timeFrame: two years
Secondary outcomes:
measure: Adverse events
timeFrame: two years
measure: Tumor response
timeFrame: two years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Frist Affliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Ming Kuang, PhD
role: STUDY_CHAIR
References: