Clinical trial · Interventional
EUS-RFA PANCARDINAL-1 Trial
A Single-arm Phase II Study to Evaluate the Safety and Efficacy of Combination Systematic Chemotherapy and Multiple Rounds of Endoscopic Ultrasound-guided Radiofrequency Ablation in Pancreatic Cancer
- 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)
The objectives of this study are to determine the feasibility, tolerability, and treatment effect of endoscopic ultrasound (EUS) radiofrequency ablation (RFA) plus standard-of-care neoadjuvant chemotherapy (NAC) in the treatment of pancreatic ductal adenocarcinoma (PDAC). Endoscopic ultrasound (EUS) radiofrequency ablation (RFA) and neoadjuvant chemotherapy (NAC) will be performed before tumor resection surgery, with the goal of shrinking a tumor or stopping the spread of cancer so that surgery might be less invasive and more effective.
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 Ductal Adenocarcinoma (PDAC) | Pancreatic Ductal Adenocarcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic Ultrasound (EUS)-Guided Radiofrequency Ablation (RFA) | Device | — | UNRESOLVED |
| Neoadjuvant Chemotherapy (NAC) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Neoadjuvant chemotherapy (NAC) plus endoscopic ultrasound (EUS) radiofrequency ablation (RFA)
- interventionNames
- Device: Endoscopic Ultrasound (EUS)-Guided Radiofrequency Ablation (RFA)
- Drug: Neoadjuvant Chemotherapy (NAC)
Primary outcomes (1)
- measure
- Number of participants who are able to complete neoadjuvant chemotherapy plus EUS-RFA and later undergo surgical tumor resection
- timeFrame
- From the time of EUS-RFA NAC intervention to the time of surgical tumor resection (about 5-6 months)
Secondary outcomes (4)
- measure
- Radiographic treatment response as assessed by standard Response evaluation criteria in solid tumors (RECIST) criteria
- timeFrame
- 2 months after the initiation of chemotherapy
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosed and histologically-confirmed PDAC by biopsy * Permanent street address * Consent to study participation * Axial CT scan consistent with PDAC * No prior chemotherapy or less than 2 months of pre-operative chemotherapy for PDAC * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 Exclusion Criteria: * Male or female patients \< 18 years of age * No permanent street address or telephone number * Pregnant patients * Inmates or prisoners * Unable to provide informed consent
References
Publications (0)
Data not yet available