Clinical trial · Interventional
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
NCT03882866CI-TRIAL-00043231unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3D-printed coplanar template | Procedure | — | UNRESOLVED |
| 3D-printed non-coplanar template | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 3D-printed non-coplanar template
- description
- 3D-printed non-coplanar template is used in this group.
- interventionNames
- Procedure: 3D-printed non-coplanar template
- type
- ACTIVE_COMPARATOR
- label
- 3D-printed coplanar template
- description
- 3D-printed coplanar template is used in this group.
- interventionNames
- Procedure: 3D-printed coplanar template
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.