Actively Recruiting
Implantation of iodine125-Seeds Combined With Chemotherapy in the Treatment of Metastatic Pancreatic Carcinoma
Led by Changhai Hospital · Updated on 2023-08-04
206
Participants Needed
1
Research Sites
226 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Implantation of iodine125-Seeds Combined With Chemotherapy in the Treatment of Metastatic Pancreatic Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Stage IV pancreatic ductal adenocarcinoma with distant metastases confirmed by clinical, imaging, and pathology
- Primary and metastatic tumors measurable on imaging
- No previous chemotherapy, radiotherapy, or surgery for pancreatic cancer
- Expected survival longer than 6 months
- ECOG performance status score of 0 to 2
- Eligible for chemotherapy with adequate blood counts and organ function
- Signed written informed consent
You will not qualify if you...
- Contraindications or technical issues preventing endoscopic ultrasound-guided procedure
- Pregnant or breastfeeding
- Presence of brain metastases
- Deep vein thrombosis or pulmonary embolism
- Active infections including HIV, HBV, or HCV that cannot be controlled
- Allergy or hypersensitivity to chemotherapy drugs
- History of other cancers within the past 5 years
- Peripheral neuropathy or interstitial lung disease within the past 5 years
- Currently participating in another clinical trial
AI-Screening
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Trial Site Locations
Total: 1 location
1
Changhai Hospital
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
Research Team
J
Jia Yi Ma, M.D
CONTACT
K
Kai Xuan Wang, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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