A comparison of combined EUS-guided radiofrequency ablation using EUSRA RF electrode and chemotherapy vs. chemotherapy alone in locally advanced pancreatic cancer: a phase II/III randomized controlled trial

Phase 2

Recruiting

• Conditions: ocally advanced unresectable pancreatic ductal adenocarcinoma; Radiofrequency ablation; Endoscopic ultrasound; Locally advanced pancreatic cancer

• Registration Number: TCTR20201223001
• Lead Sponsor: Scholarship

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-23
• Study Completion: 2021-07-03
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

1. Histology or cytology confirmed locally advanced unresectable pancreatic ductal adenocarcinoma patients (AJCC 8th stage III)
2. ECOG status below or equal to 2
3. Age 18 - 85 years old and willing to participate in a clinical trial

Exclusion Criteria

1. Patients with technical restriction in performing EUS-guided radiofrequency ablation
2. Pregnant women
3. Prior received standard treatment for pancreatic cancer
4. Patients with uncorrectable coagulopathy (INR > 1.5 times upper normal limit, aPTT > 2 times upper normal limit or platelet < 50,000)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival at 6 months after end of intervention Time to death from start of treatment

Secondary Outcome Measures

Name	Time	Method
Progression free survival at 6 months after end of intervention Time to first progression event or death from start of treatment,Objective tumor response at 6 months after end of intervention Measured the tumor response following RECIST and mRECIST version 1.1,Multi-dimensional pain assessment From baseline up to 6 months Self-assessment brief pain inventory score and change in morphine dosage equivalent,Quality of life From baseline up to 6 months EORTC-QLQ C-30 score - PAN26,Participants with treatment adverse events From baseline up to 6 months Adverse events after treatment followed Common Terminology Criteria for Adverse Events v5.0