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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
206
Endoscopic ultrasound-guided intratumoral iodine125-Seeds implantation
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
Changhai Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGOverall survival (OS)
OS is defined as the time from the date of randomization to the date of death (any cause). Patients who are alive will be censored at the last known time that the patient was alive.
Time frame: 48 months
Incidence and severity of Adverse events (AEs)
AEs are graded and reported using The CTCAE version 5.0.
Time frame: 48 months
Progression-free survival (PFS)
PFS is defined as the time from the date of randomization to the date of objective disease progression according to RECIST 1.1 criteria or death (due to any cause),whichever occurs first.
Time frame: 48 months
Overall Response Rate (ORR)
ORR is defined as the percentage of patients with an investigator-assessed complete (CR) or partial response (PR) according to RECIST v1.1.
Time frame: 48 months
CA19-9 response
CA19-9 response is defined as a decrease of CA19-9 concentration by 50% from the prespecified baseline concentration of 74 U/mL or more.
Time frame: 48 months
Metabolic response
Metabolic response is evaluated by PET/CT according to EORTC criteria.
Time frame: from baseline to the end of 2nd chemotherapy cycle
Visual analog scale (VAS)
Pain is scored according to a VAS score, with a score of 0 indicating no pain and a score of 10 indicating the most intense degree of pain (unbearable pain).
Time frame: 48 months
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