RecruitingNot ApplicableNCT05869474

Implantation of iodine125-Seeds Combined With Chemotherapy in the Treatment of Metastatic Pancreatic Carcinoma

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

Sponsor

Changhai Hospital

Enrollment

206 participants

Start Date

Aug 1, 2023

Study Type

INTERVENTIONAL

Conditions

Metastatic Pancreatic Cancer

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of radioactive seed implants (tiny pellets placed directly into tumours to deliver radiation from the inside) plus chemotherapy for people with stage IV pancreatic cancer that has spread to other organs. **You may be eligible if...** - You are between 18 and 80 years old - You have stage IV pancreatic ductal adenocarcinoma (confirmed by imaging and biopsy) with distant spread - You have not previously received chemotherapy, radiotherapy, or surgery for this cancer - Your expected survival is more than 6 months - Your blood counts and organ function are adequate **You may NOT be eligible if...** - You have previously received treatment for pancreatic cancer - Your organ function (liver, kidneys, blood counts) does not meet the required levels - You are too unwell to tolerate chemotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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