2023-08-01
2027-12
2027-12
206
NCT05869474
Changhai Hospital
Changhai Hospital
INTERVENTIONAL
Implantation of iodine125-Seeds Combined With Chemotherapy in the Treatment of Metastatic Pancreatic Carcinoma
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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2023-05-11 | N/A | 2023-08-03 |
2023-05-11 | N/A | 2023-08-04 |
2023-05-22 | N/A | 2023-08 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Double
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: I125-AG Participants will receive the implantation of radioactive seeds under EUS guide. 48h after implantation, chemotherapy with Gemcitabine 1000mg/m2 plus albumin paclitaxel 125mg/m2 given on days 1 and 8 of each 21-day cycle will be conducted. | PROCEDURE: Iodine125-Seeds implantation
DRUG: Gem/nab-P Chemotherapy
|
| ACTIVE_COMPARATOR: AG Participants receive chemotherapy alone. Gemcitabine 1000mg/m2 plus albumin paclitaxel 125mg/m2 given on days 1 and 8 of each 21-day cycle. | PROCEDURE: Iodine125-Seeds implantation
DRUG: Gem/nab-P Chemotherapy
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Overall 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. | 48 months |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Incidence and severity of Adverse events (AEs) | AEs are graded and reported using The CTCAE version 5.0. | 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. | 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. | 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. | 48 months |
| Metabolic response | Metabolic response is evaluated by PET/CT according to EORTC criteria. | 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). | 48 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Jia Yi Ma, M.D Phone Number: +8613621819595 Email: 504043536@qq.com |
Study Contact Backup Name: Kai Xuan Wang, M.D Phone Number: Email: wangkaixuan224007@163.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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