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Pancreatic Ductal Adenocarcinoma (PDAC)Phase 2NCT04990609

EUS-RFA PANCARDINAL-1 Trial

A Phase 2 study testing Endoscopic Ultrasound (EUS)-Guided Radiofrequency Ablation (RFA) and Neoadjuvant Chemotherapy (NAC) in people with Pancreatic Ductal Adenocarcinoma (PDAC), run by The University of Texas Health Science Center, Houston at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Ductal Adenocarcinoma (PDAC)
What is being tested?
Endoscopic Ultrasound (EUS)-Guided Radiofrequency Ablation (RFA) and Neoadjuvant Chemotherapy (NAC)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
13 Aug 2021to 30 May 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Amatullah Alibhai, B.A., M.B.A. contact

713-486-1443

amatullah.alibhai@uth.tmc.edu

Nicole Fatheree, B.B.A. contact

713-500-5669

Nicole.Fatheree@uth.tmc.edu

United States1 site, 1 recruiting

  • Memorial Hermann Hospital

    Houston, Texas, 77030

    Amatullah Alibhai, B.A., M.B.A., 713-486-1443, amatullah.alibhai@uth.tmc.edu

    Nicole Fatheree, B.B.A., 713-500-5669, Nicole.Fatheree@uth.tmc.edu

    Recruiting

Other trials in United States

About this study

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

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.

Being tested
Endoscopic Ultrasound (EUS)-Guided Radiofrequency Ablation (RFA), Neoadjuvant Chemotherapy (NAC)
Keywords
Endoscopic Ultrasound Radiofrequency ablation (EUS-RFA)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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)].

Study groups in NCT04990609
Study groupRoleWhat they receive
Neoadjuvant chemotherapy (NAC) plus endoscopic ultrasound (EUS) radiofrequency ablation (RFA)ExperimentalNot described
Receives: Device: Endoscopic Ultrasound (EUS)-Guided Radiofrequency Ablation (RFA); Drug: Neoadjuvant Chemotherapy (NAC)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

Secondary outcomes (4)

  1. 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

    Measured: 2 months after the initiation of chemotherapy

  2. 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

    Measured: 4 months after the initiation of chemotherapy

  3. Number of participants with post-operative complications

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

  4. Disease-free survival time

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2021
  2. Study start13 Aug 2021
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion30 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04990609
Sponsor's protocol ID
HSC-MS-21-0066
Other IDs
R01CA277161-01A1
Status last verified
Jul 2026
First submitted
2 Feb 2021
Last updated
29 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Endoscopic Ultrasound (EUS)-Guided Radiofrequency Ablation (RFA) and Neoadjuvant Chemotherapy (NAC) in people with Pancreatic Ductal Adenocarcinoma (PDAC), run by The University of Texas Health Science Center, Houston at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Amatullah Alibhai, B.A., M.B.A. (713-486-1443, amatullah.alibhai@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04990609.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.

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