NCT05869474 Implantation of iodine125-Seeds Combined With Chemotherapy in the Treatment of Metastatic Pancreatic Carcinoma
| NCT ID | NCT05869474 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Changhai Hospital |
| Condition | Metastatic Pancreatic Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 206 participants |
| Start Date | 2023-08-01 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 206 participants in total. It began in 2023-08-01 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Zhao Shen Li, M.D
PRINCIPAL INVESTIGATOR
Department of Gastroenterology, Changhai Hospital, Naval Medical University (Second Military Medical University), Shanghai, China.
Frequently Asked Questions
Who can join the NCT05869474 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Metastatic Pancreatic Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05869474 currently recruiting?
Yes, NCT05869474 is actively recruiting participants. Contact the research team at 504043536@qq.com for enrollment information.
Where is the NCT05869474 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT05869474 clinical trial?
NCT05869474 is sponsored by Changhai Hospital. The principal investigator is Zhao Shen Li, M.D at Department of Gastroenterology, Changhai Hospital, Naval Medical University (Second Military Medical University), Shanghai, China.. The trial plans to enroll 206 participants.
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