About this trial
this is a randomized controlled trial aims to compare between patients with locally advanced pancreatic cancer treated with EUS-guided injection of gemcitabine in addition to systemic chemotherapy, versus those who treated with the standard systemic chemotherapy alone, regarding to(progression -free survival and response rate).
Researchers will compare Arm A: patients received EUS-FNI of gemcitabine plus standard systemic chemotherapy to Arm B : patients receiving the standard systemic chemotherapy alone.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age > 18 years old.
Patients recently diagnosed to have pancreatic adenocarcinoma based on histopathological examination.
Locally advanced potentially resectable pancreatic cancer . .Eastern Cooperative Oncology Group performance status of 0 to 1. .Signed informed consent.
Disqualifiers
Age < 18 years old.
Metastatic pancreatic cancer.
prior pancreatic surgery or chemotherapy or radiotherapy. concurrent or prior malignancy. coexistent medical condition precluding protocol therapy.
Trial design
Parallel
Treatments tested in this trial
endoscopic ultrasonograhy guided chemptherapy injection
Drugendoscopic ultrasonograhy guided chemptherapy injection
Treatment groups
Trial outcomes
Primary outcomes
compare patients with locally advanced pancreatic cancer treated with EUS guided injection of gemcitabine plus systemic chemotherapy to those treated with the standard systemic chemotherapy alone, regarding to(progression -freesurvival and response rate)
The primary outcome of this study is to compare the progression-free survival between patients with locally advanced pancreatic cancer who receive EUS-guided injection of gemcitabine plus systemic chemotherapy (Arm A) and those who receive standard systemic chemotherapy alone (Arm B). Progression-free survival is defined as the time from randomization to the first documented progression of disease (as per RECIST criteria) or death, whichever occurs first. The secondary outcome will be the comparison of the response rate between the two treatment arms. Objective response rate will be measured as the proportion of patients who achieve either complete response (CR) or partial response (PR) to treatment, according to RECIST criteria. By evaluating both progression-free survival and response rate, the trial aims to determine whether the addition of EUS-guided gemcitabine injection enhances the effectiveness of systemic chemotherapy in treating locally advanced pancreatic cancer
Locations
Sponsors and contacts
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