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NCT Number: NCT04990609

EUS-RFA PANCARDINAL-1 Trial

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.

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Key information

Conditions

Pancreatic Ductal Adenocarcinoma (PDAC)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Curtis Wray, MD

SUB_INVESTIGATOR

Jennifer Bailey, PhD, MA

PRINCIPAL_INVESTIGATOR

Nirav Thosani, MD

CONTACT

[email protected]

713-486-1350

Nirav Thosani, MD, MHA

PRINCIPAL_INVESTIGATOR

Sofia C Colon, BS

CONTACT

[email protected]

713-500-6658

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

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.

Neoadjuvant Chemotherapy (NAC)

Drug

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

Primary outcomes

  1. 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

  1. Radiographic treatment response as assessed by standard Response evaluation criteria in solid tumors (RECIST) criteria

    Time frame: 2 months after the initiation of chemotherapy

    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. Radiographic treatment response as assessed by standard Response evaluation criteria in solid tumors (RECIST) criteria

    Time frame: 4 months after the initiation of chemotherapy

    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

  3. Number of participants with post-operative complications

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

  4. Disease-free survival time

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Nirav Thosani, MD

CONTACT

[email protected]

713-486-1350

Sofia C Colon, BS

CONTACT

[email protected]

713-500-6658

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2026
Study completion
2028
First posted
Aug 4, 2021
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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