Implantation of iodine125-Seeds Combined With Chemotherapy in the Treatment of Metastatic Pancreatic Carcinoma
Metastatic Pancreatic Cancer
About this trial
This is an interventional treatment trial for Metastatic Pancreatic Cancer focused on measuring iodine 125, EUS-guided implantation, chemotherapy
Eligibility Criteria
Inclusion Criteria: (Before the trial, subjects must meet all of the requirements listed below in order to be enrolled) 18 to 80 years old; Stage IV pancreatic ductal adenocarcinoma with distant metastases confirmed by clinical, imaging, and pathology, and the primary and metastatic mass can be measured on imaging. No treatment history of chemotherapy, radiotherapy, or surgery Expected survival > 6 months ECGO score of 0-2 Eligible for chemotherapy (white blood cell > 3.5×109/L, neutrophil value > 1.5×109/L, hemoglobin > 80g/L, platelets > 100×109/L, albumin > 25g/L, alanine aminotransferase or aspartate aminotransferase ≤ 3 times the upper limit of normal and total bilirubin level ≤ 34.2umol/L, creatinine < 176.8 umol/L, normal ECG) Signed written informed consent; Exclusion Criteria: Contraindication of EUS-guide procedure or technical infeasibility (e.g.,coagulation disorder, anatomical changes, large vessels along the puncture path) Pregnant or breastfeeding Presence of brain metastases Presence of deep vein thrombosis or pulmonary embolism Presence of HIV, HBV, HCV infection or other uncontrollable active infection Hypersensitivity to chemotherapy drugs History of other malignancies within 5 years Peripheral neuropathy or interstitial lung disease within 5 years Patient is enrolled in any other clinical protocol or investigational trial.
Sites / Locations
- Changhai HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
I125-AG
AG
Participants will receive the implantation of radioactive seeds under EUS guide. 48h after implantation, chemotherapy with Gemcitabine 1000mg/m2 plus albumin paclitaxel 125mg/m2 given on days 1 and 8 of each 21-day cycle will be conducted.
Participants receive chemotherapy alone. Gemcitabine 1000mg/m2 plus albumin paclitaxel 125mg/m2 given on days 1 and 8 of each 21-day cycle.