Implantation of iodine125-Seeds Combined With Chemotherapy in the Treatment of Metastatic Pancreatic Carcinoma

NCT05869474 · tracked via the Priya Life Science China tracker

Sponsor

Changhai Hospital

Phase

Not applicable

Started

2023-08-01

Last updated

2023-08-04

Condition(s) studied

Metastatic Pancreatic Cancer

Investigational drug(s) / intervention(s)

Iodine125-Seeds implantationGem/nab-P Chemotherapy

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

Study 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

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

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.

Primary outcome measure(s)

Overall survival (OS) — 48 months
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.

Trial sites (1)

Facility	City	Region	Status
Changhai Hospital	Shanghai	Shanghai Municipality	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05869474 on ClinicalTrials.gov ↗ ← All trials in China