Last updated: August 3, 2023
Sponsor: Changhai Hospital
Overall Status: Active - Recruiting
Phase
N/A
Condition
Digestive System Neoplasms
Metastatic Cancer
Treatment
Iodine125-Seeds implantation
Gem/nab-P Chemotherapy
Clinical Study ID
NCT05869474
2022-219
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
(Before the trial, subjects must meet all of the requirements listed below in order to beenrolled)
- 18 to 80 years old;
- Stage IV pancreatic ductal adenocarcinoma with distant metastases confirmed byclinical, imaging, and pathology, and the primary and metastatic mass can be measuredon 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 aminotransferaseor aspartate aminotransferase ≤ 3 times the upper limit of normal and total bilirubinlevel ≤ 34.2umol/L, creatinine < 176.8 umol/L, normal ECG)
- Signed written informed consent;
Exclusion
Exclusion Criteria:
- Contraindication of EUS-guide procedure or technical infeasibility (e.g.,coagulationdisorder, 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.
Study Design
Total Participants: 206
Treatment Group(s): 2
Primary Treatment: Iodine125-Seeds implantation
Phase:
Study Start date:
August 01, 2023
Estimated Completion Date:
December 31, 2027
Connect with a study center
Changhai Hospital
Shanghai, Shanghai 200433
ChinaActive - Recruiting

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