Borderline Resectable Pancreatic Cancer Neoadjuvant Chemoradiotherapy Clinicaltrial-1

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study is to investigate whether neoadjuvant chemotherapy plus SBRT results in better outcomes compared with neoadjuvant chemotherapy alone and also compare the efficacy of gemcitabine plus nab-paclitaxel with SBRT and S-1 plus nab-paclitaxel with SBRT.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Changhai Hospital
• Treatments: Albumin-Bound Paclitaxel; Gemcitabine; Paclitaxel

Criteria

Inclusion Criteria:

• Age≥18 years old and ≤80 years old;

• Histological proven pancreatic adenocarcinoma;

• Borderline resectable pancreatic cancer proven by imaging examinations via multidisciplinary approaches according to NCCN guidelines;

• No prior chemotherapy or radiotherapy;

• ECOG of 0 or 1;

• Routine blood test: absolute neutrophil count>1500/mm3, platelet>100000/mm3;

• Normal liver function: serum total bilirubin≤2.0mg/dl, ALT and AST<2.5 times of the upper limit of normal value;

• Normal kidney function: serum creatinine<1.5 times of the upper limit of normal value or creatinine clearance rate>45ml/min;

• No severe comorbidities.

Exclusion Criteria:

• Metastatic pancreatic cancer;

• Patients who had surgeries, chemotherapy or other treatments before inclusion;

• Impaired organ functions: heart failure (New York Heart Association III-IV), coronary heart disease, myocardial infarction within 6 months, severe cardiac arrhythmia and respiratory failure;

• Confirmed other cancer within 5 years;

• Pregnant women or lactating women;

• Patients enrolled in other clinical trials or incompliant of regular follow up;

• Patients who did not provide an informed consent.