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Implantation of iodine125-Seeds Combined With Chemotherapy in the Treatment of Metastatic Pancreatic Carcinoma
Sponsor: Changhai Hospital
Summary
The goal of this clinical trial is to evaluate the clinical efficacy and safety of endoscopic ultrasonography (EUS)-guided radioactive iodine 125 seeds in combination with AG regimen chemotherapy for the treatment of metastatic pancreatic cancer. The main questions it aims to answer are: * whether the combination of minimally invasive endoscopy-guided local radiation therapy with chemotherapy may improve overall survival * the adverse events of the combination therapy Participants will receive the implantation of radioactive seeds under EUS guide. 48h after implantation, chemotherapy with Gem/nab-P given on days 1 and 8 of each 21-day cycle will be conducted. Researchers will compare the I125+AG group with the group that takes AG chemotherapy alone to see if the overall survival can be improved.
Official title: Endoscopic Ultrasound-guided Intratumoral Iodine125-Seeds Implantation Combined With Gem/Nab-P Chemotherapy Versus Gem/Nab-P Alone for Metastatic Pancreatic Carcinoma: a Randomized, Controlled, Trial
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
206
Start Date
2023-08-01
Completion Date
2027-12
Last Updated
2023-08-04
Healthy Volunteers
No
Conditions
Interventions
Iodine125-Seeds implantation
Endoscopic ultrasound-guided intratumoral iodine125-Seeds implantation
Gem/nab-P Chemotherapy
nab-paclitaxel (125 mg per square meter of body-surface area) followed by gemcitabine (1000 mg per square meter) on days 1, 8 every 3 weeks
Locations (1)
Changhai Hospital
Shanghai, Shanghai Municipality, China