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

Pancreatic Ductal Adenocarcinoma (PDAC) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04990609
• Other study ID #: HSC-MS-21-0066
• Status: Recruiting
• Phase: Phase 2
• Start date: August 13, 2021
• Est. completion date: January 30, 2028

Study information

• Verified date: April 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: Prithvi B Patil, MS
• Phone: 7135006456
• Email: prithvi.b.patil[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: January 30, 2028
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed and histologically confirmed PDAC by biopsy

• Permanent street address and 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 0-2

Exclusion Criteria:

• No phone number of Male or Female patients > 18 years of age

• Diagnosed and histologically confirmed PDAC by biopsy

• No permanent street address or telephone number

• Pregnant patients

• Inmates or prisoners

• Unable to provide informed consent

Related Conditions & MeSH terms

• Pancreatic Ductal Adenocarcinoma (PDAC)

Intervention

Device:
• Endoscopic Ultrasound (EUS)-Guided Radiofrequency Ablation (RFA)
Endoscopic Ultrasound (EUS)-guided Radiofrequency Ablation (RFA) consists of the application of alternating current with a frequency of 350-500 kilohertz (kHz) to the target tissue via a special electrode located at the tip of an echoendoscope. The alternating current causes the vibratory movement of ionic particles in the abutting and adjoining tissue and results in the generation of heat. However, RFA induces not only local disruption of the tumor by heat, but it also produces localized coagulation necrosis of the tumor which induces the release of large amounts of cellular debris which represent a source of tumor antigens that can trigger a host adaptive immune response against the tumor.

Drug:
• Neoadjuvant chemotherapy (NAC)
The NAC regimen will be determined clinically by the participant's physician [possible regimens are either mFOLFIRINOX or Gemcitabine Nab-Paclitaxel +/- Cisplatin (GemAbraxane)].

Locations

Country	Name	City	State
United States	Memorial Hermann Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who are able to complete neoadjuvant chemotherapy plus EUS-RFA and later undergo surgical tumor resection		From the time of EUS-RFA NAC intervention to the time of surgical tumor resection (about 5-6 months)
Secondary	Radiographic treatment response as assessed by standard Response evaluation criteria in solid tumors (RECIST) criteria	Using the RECIST criteria, treatment response is categorized as follows: Complete response (CR): Disappearance of all target lesions; Partial response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started; Progressive disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions	2 months after the initiation of chemotherapy
Secondary	Radiographic treatment response as assessed by standard Response evaluation criteria in solid tumors (RECIST) criteria	Using the RECIST criteria, treatment response is categorized as follows: Complete response (CR): Disappearance of all target lesions; Partial response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started; Progressive disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions	4 months after the initiation of chemotherapy
Secondary	Number of participants with post-operative complications		from the time of surgical tumor resection to 90 days following surgical tumor resection
Secondary	Disease-free survival time	Disease is defined as clinical evidence of local or distant recurrence.	from the time of diagnosis to time of recurrence (or up to 5 years after diagnosis, whichever occurs first)