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

Endoscopic Ultrasound-guided Intratumoral Iodine125-Seeds Implantation Combined With Gem/Nab-P Chemotherapy Versus Gem/Nab-P Alone for Metastatic Pancreatic Carcinoma: a Randomized, Controlled, Trial

This study is testing if combining radioactive iodine seeds with chemotherapy can help people with metastatic pancreatic cancer live longer compared to just chemotherapy alone.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 206 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Changhai Hospital (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT05869474 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with stage IV pancreatic ductal adenocarcinoma and measurable metastatic disease who have not received prior chemotherapy, radiotherapy, or surgery.

Not a fit: Patients with contraindications to the EUS-guided procedure or those who have received prior treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance overall survival rates for patients with metastatic pancreatic cancer.

How similar studies have performed: While the combination of local radiation therapy and chemotherapy is a novel approach, similar studies have shown promise in improving outcomes for other cancers.

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.

Where this trial is running

Shanghai, Shanghai Municipality

• 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

Conditions Metastatic Pancreatic Cancer; iodine 125; EUS-guided implantation; chemotherapy