Using iodine-125 seeds and chemotherapy to treat metastatic pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the safety and efficacy of endoscopic ultrasonography (EUS)-guided implantation of radioactive iodine-125 seeds combined with chemotherapy for patients with metastatic pancreatic cancer. Participants will receive the radioactive seed implantation followed by chemotherapy with Gemcitabine and nab-Paclitaxel on specific days of a 21-day cycle. The study will compare outcomes between those receiving the combination therapy and those receiving chemotherapy alone to determine if overall survival can be improved.

Why it matters

Who can join: the full rules

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.

Where it's running

• Changhai Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Zhao Shen Li, M.D — Department of Gastroenterology, Changhai Hospital, Naval Medical University (Second Military Medical University), Shanghai, China.
• Study coordinator: Jia Yi Ma, M.D
• Email: 504043536@qq.com
• Phone: +8613621819595

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.