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Trial Title:
Implantation of iodine125-Seeds Combined With Chemotherapy in the Treatment of Metastatic Pancreatic Carcinoma
NCT ID:
NCT05869474
Condition:
Metastatic Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Conditions: Keywords:
iodine 125
EUS-guided implantation
chemotherapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Care Provider, Outcomes Assessor)
Masking description:
Patients will be randomly assigned(1:1) to the two treatment groups by an independent
staff who is not involved in the treatment. The endoscopist and patient are not masked
because they exactly know whether EUS-guided implantation is performed or not. Survival
will be assessed by blinded researchers during follow-up.
Intervention:
Intervention type:
Procedure
Intervention name:
Iodine125-Seeds implantation
Description:
Endoscopic ultrasound-guided intratumoral iodine125-Seeds implantation
Arm group label:
I125-AG
Intervention type:
Drug
Intervention name:
Gem/nab-P Chemotherapy
Description:
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
Arm group label:
AG
Arm group label:
I125-AG
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
(Before the trial, subjects must meet all of the requirements listed below in order to be
enrolled)
1. 18 to 80 years old;
2. 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.
3. No treatment history of chemotherapy, radiotherapy, or surgery
4. Expected survival > 6 months
5. ECGO score of 0-2
6. 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)
7. Signed written informed consent;
Exclusion Criteria:
1. Contraindication of EUS-guide procedure or technical infeasibility (e.g.,coagulation
disorder, anatomical changes, large vessels along the puncture path)
2. Pregnant or breastfeeding
3. Presence of brain metastases
4. Presence of deep vein thrombosis or pulmonary embolism
5. Presence of HIV, HBV, HCV infection or other uncontrollable active infection
6. Hypersensitivity to chemotherapy drugs
7. History of other malignancies within 5 years
8. Peripheral neuropathy or interstitial lung disease within 5 years
9. Patient is enrolled in any other clinical protocol or investigational trial.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Changhai Hospital
Address:
City:
Shanghai
Zip:
200433
Country:
China
Status:
Recruiting
Contact:
Last name:
Kaixuan Wang, MD
Phone:
86-21-31161353
Email:
wangkaixuan224007@sina.com
Start date:
August 1, 2023
Completion date:
December 2027
Lead sponsor:
Agency:
Changhai Hospital
Agency class:
Other
Source:
Changhai Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05869474
