EUS-RFA PANCARDINAL-1 Trial

Phase 2RecruitingNCT04990609

The University of Texas Health Science Center, Houston60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pancreatic Ductal Adenocarcinoma (PDAC)

Interventions

Endoscopic Ultrasound (EUS)-Guided Radiofrequency Ablation (RFA)

Endoscopic ultrasound (EUS)-guided radiofrequency ablation (RFA) consists of the application of an 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. This cellular debris represents a source of tumor antigens that can trigger a host adaptive immune response against the tumor.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of participants who are able to complete neoadjuvant chemotherapy plus EUS-RFA and later undergo surgical tumor resection

Time frame: From the time of EUS-RFA NAC intervention to the time of surgical tumor resection (about 5-6 months)

Secondary Outcomes

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

Time frame: 2 months after the initiation of chemotherapy

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

Time frame: 4 months after the initiation of chemotherapy

Number of participants with post-operative complications

Time frame: from the time of surgical tumor resection to 90 days following surgical tumor resection

Disease-free survival time

Disease is defined as clinical evidence of local or distant recurrence.

Time frame: from the time of diagnosis to time of recurrence (or up to 5 years after diagnosis, whichever occurs first)