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
1 other identifier
interventional
206
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2023
CompletedFirst Posted
Study publicly available on registry
May 22, 2023
CompletedStudy Start
First participant enrolled
August 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
August 4, 2023
August 1, 2023
4.3 years
May 11, 2023
August 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Incidence and severity of Adverse events (AEs)
48 months
Progression-free survival (PFS)
48 months
Overall Response Rate (ORR)
48 months
CA19-9 response
48 months
Metabolic response
from baseline to the end of 2nd chemotherapy cycle
- +1 more secondary outcomes
Study Arms (2)
I125-AG
EXPERIMENTALParticipants 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.
AG
ACTIVE COMPARATORParticipants receive chemotherapy alone. Gemcitabine 1000mg/m2 plus albumin paclitaxel 125mg/m2 given on days 1 and 8 of each 21-day cycle.
Interventions
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
Eligibility Criteria
You may qualify if:
- (Before the trial, subjects must meet all of the requirements listed below in order to be enrolled)
- to 80 years old;
- 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.
- No treatment history of chemotherapy, radiotherapy, or surgery
- Expected survival \> 6 months
- ECGO score of 0-2
- 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)
- Signed written informed consent;
You may not qualify if:
- Contraindication of EUS-guide procedure or technical infeasibility (e.g.,coagulation disorder, anatomical changes, large vessels along the puncture path)
- Pregnant or breastfeeding
- Presence of brain metastases
- Presence of deep vein thrombosis or pulmonary embolism
- Presence of HIV, HBV, HCV infection or other uncontrollable active infection
- Hypersensitivity to chemotherapy drugs
- History of other malignancies within 5 years
- Peripheral neuropathy or interstitial lung disease within 5 years
- Patient is enrolled in any other clinical protocol or investigational trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Changhai Hospital
Shanghai, Shanghai Municipality, 200433, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhao Shen Li, M.D
Department of Gastroenterology, Changhai Hospital, Naval Medical University (Second Military Medical University), Shanghai, China.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of Gastroenterology, Changhai Hospital
Study Record Dates
First Submitted
May 11, 2023
First Posted
May 22, 2023
Study Start
August 1, 2023
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
August 4, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share