Iodine-125 Seed Implantation Therapy for Locally Advanced Pancreatic Cancer

3D-printed Template for Iodine-125 Seed Implantation Therapy in Patients With Locally Advanced Pancreatic Cancer: a Multicenter Study

This study evaluates the application of 3D-printed template for iodine-125 seed implantation therapy in patients with locally advanced pancreatic cancer. Half of participants will receive 3D-printed coplanar template, while the other half will receive 3D-printed non-coplanar template.

Dosimetric verification was performed after implantation. Pre- and postoperative D90, V100, and V150 were calculated. The success rate of iodine-125 seed implantation, dosimetric parameters, objective response rate (ORR)，overall survival (OS)，toxicities and quality of life of two treatment regimens and complications were analyzed and compared between the two groups.

Inclusion Criteria:

• Age: 18-80 years

• Cytologically or histologically confirmed pancreatic adenocarcinoma

• Inoperable locally advanced pancreatic cancer based on American Joint Committee on Cancer (AJCC) staging system (8th ed) (without distant metastasis)

• Single tumor size≤ 6 cm

• Karnofsky performance score （KPS）≥60

• Estimated survival ≥3 months

• Without other several comorbidity

• Participants must have adequate organ function:

  • WBC≥3×109/L; HGB≥90g/dL; PLT≥50×109/L
  • Aspartate Transaminase (AST)/alanine aminotransferase ( ALT) ≤3 × institutional upper limit of normal
  • Albumin≥3g/dL
  • Total bilirubin ≤3mg/dL
  • PT≤3 × institutional upper limit of normal or INR≤2.3
  • Creatinine ≤1.5 × institutional upper limit of normal

• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

• Patients with other malignant tumors
• History of other anti-cancer therapy, including surgery,radiation, ablation and so on
• Pregnant or lactating women
• Patients with Immunodeficiency disease
• Several heart disease, for example: New York Heart Association (NYHA) class III/IV congestive heart failure，active coronary heart disease and severe arrhythmia
• Uncontrolled hypertension
• Ongoing or active infection (>grade 2 based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) 4.0 edition)
• Active tuberculosis
• Chronic renal insufficiency
• Other organ failure
• History of organ transplantation
• History of severe mental illness