Implantation of iodine125-Seeds Combined With Chemotherapy in the Treatment of Metastatic Pancreatic Carcinoma
NCT ID: NCT05869474
Last Updated: 2023-08-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
206 participants
INTERVENTIONAL
2023-08-01
2027-12-31
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
Iodine125-Seeds implantation
Endoscopic ultrasound-guided intratumoral iodine125-Seeds implantation
Gem/nab-P Chemotherapy
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
AG
Participants receive chemotherapy alone. Gemcitabine 1000mg/m2 plus albumin paclitaxel 125mg/m2 given on days 1 and 8 of each 21-day cycle.
Gem/nab-P Chemotherapy
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
Interventions
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Iodine125-Seeds implantation
Endoscopic ultrasound-guided intratumoral iodine125-Seeds implantation
Gem/nab-P Chemotherapy
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
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Inclusion Criteria
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
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.
18 Years
80 Years
ALL
No
Sponsors
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Changhai Hospital
OTHER
Responsible Party
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Zhaoshen Li
Department of Gastroenterology, Changhai Hospital
Principal Investigators
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Zhao Shen Li, M.D
Role: PRINCIPAL_INVESTIGATOR
Department of Gastroenterology, Changhai Hospital, Naval Medical University (Second Military Medical University), Shanghai, China.
Locations
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Changhai Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022-219
Identifier Type: -
Identifier Source: org_study_id
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