Pancreatic Ductal AdenocarcinomaPhase 2PANCARDINAL-2NCT06831136
Endoscopic Ultrasound Radiofrequency Ablation and Immunotherapy Pembrolizumab for Locally Advanced Unresectable and Metastatic Pancreatic Duct Adenocarcinoma
A Phase 2 study testing Neoadjuvant Chemotherapy (NAC), Immunotherapy (pembrolizumab) and Endoscopic ultrasound (EUS)-guided radiofrequency ablation (RFA) in people with Pancreatic Ductal Adenocarcinoma, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to perform a pilot phase II trial to evaluate the safety and efficacy of combined EUS-RFA, chemotherapy, and systemic immunotherapy (pembrolizumab) for the treatment of locally advanced unresectable and metastatic Pancreatic ductal adenocarcinoma (mPDAC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma
- What is being tested?
- Neoadjuvant Chemotherapy (NAC), Immunotherapy (pembrolizumab) and Endoscopic ultrasound (EUS)-guided radiofrequency ablation (RFA)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2025to 20 Jan 2030
- 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
- Is willing and able to comply with the protocol for the duration of the study,including undergoing treatment and scheduled visits and examinations, including follow-up
- Biopsy-proven locally advanced unresectable or metastatic PDAC
- Patients who have undergone prior resection will be excluded unless there is recurrent pancreatic tumor that is amenable to EUS-RFA.
- If biliary metal stent is placed, during procedure of EUS-RFA, indwelling biliary metal stent will be removed during initial EUS-RFA and then replaced with plastic stent.
- Mental capacity to provide informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
- Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
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- At least one measurable metastatic lesion on axial imaging per Response Evaluation Criteria in Solid Tumors (RECIST) v1.
- No prior systemic therapy, including chemotherapy or chemoradiation is permitted with the following exceptions:
- Prior adjuvant therapy (including chemotherapy and/or radiotherapy) for pancreatic adenocarcinoma is permitted if standard of care neoadjuvant or adjuvant therapy was completed at least 3 months prior to study enrollment. Prior adjuvant therapy may include mFFX, NALIRIFOX, GA or Capecitabine (Xeloda).
- If started on first-line treatment for mPDAC elsewhere (i.e., not at our study site), eligible participants can have undergone 3 months of chemotherapy with clinically stable disease (defined as no evidence of clinical progression) before study entry. Note: Imaging done outside the site will need to be reviewed for a 2nd opinion to confirm stable disease.
- For patients who had prior treatment and stable disease up to 3 months and confirmed radiographically by our radiology investigators, then patients can proceed with EUS-RFA within 6-8 weeks of enrollment of study.
- Patients who have started chemotherapy within a 3-month timeframe are allowed.
- Absolute neutrophil count (ANC) ≥1 x 109/L
- Platelet count ≥75 x 109/L
- Albumin levels ≥3 g/dL
- Total serum bilirubin <2× upper limit of normal (ULN) unless secondary to Gilbert's Syndrome
- Subjects requiring biliary decompression, biliary stent, or drainage using percutaneous trans-hepatic cholangiogram are allowed (patients with a declining bilirubin status post stent placement are eligible with serum bilirubin ≤2.5 x ULN)
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) ≤3× ULN, or ≤5× ULN in cases of documented liver involvement
- Serum creatinine clearance must be ≥30 mL/minute either measured or calculated using a standard Cockcroft and Gault formula
- Prior surgery that required general anesthesia or other major surgery as defined by the Investigator must be completed at least 4 weeks before immunotherapy.
Who cannot join
- No telephone number and permanent street address
- Pregnant or breastfeeding patients; or is a male or female patient of reproductive potential who is not willing to employ effective birth control from time of screening to 90 days after the last dose
- Inmates or prisoners
- Unable to provide informed consent
- Resectable, borderline resectable PDAC.
- Known history of central nervous system (CNS) metastases
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- Has a history of another primary malignancy. Patients having the following are still eligible:
- No active stage 4 cancer
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- Adequately treated carcinoma in situ without evidence of disease
- Known low or absent dihydropyrimidine dehydrogenase (DPD) activity
- Use of strong inhibitors or inducers of Cytochrome P450 3A (CYP3A), CYP2C8 and UGT1A1
- History or evidence of clinically significant or uncontrolled cardiovascular, CNS,and/or other systemic disease that in the investigator's opinion would preclude participation in the study or compromise the patient's ability to give informed consent
- History of HIV or active tuberculosis (TB) (PPD response without active TB is allowed)
- Underlying medical conditions that, in the Investigator's opinion, will make the administration of pembrolizumab hazardous (e.g., interstitial lung disease, active infections requiring antibiotics, recent hospitalization with unresolved symptoms)
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
- Any active autoimmune disease or a documented history of autoimmune disease or history of a syndrome that required systemic steroids or immunosuppressive medications, except for vitiligo or resolved childhood asthma/atopy and the following scenarios below:
- Participants with asthma who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study.
- Physiologic doses of corticosteroids (≤10 mg/day of prednisone or its equivalent) or short pulses of corticosteroids (≤3 days) may be permitted.
- Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
- Patients having any chronic skin condition that does not require systemic therapy
- Patients without active disease in the last 5 years (allowed only after consultation with the study physician)
- Patients with celiac disease controlled by diet alone
- Is currently using or previously used immunosuppressive medication within 14 days before the first dose of pembrolizumab. The following medications are exceptions to this criterion:
- intranasal, inhaled, topical steroid, or local steroid injections (e.g., intra articular injection)
- Systemic corticosteroids at physiologic doses not to exceed 10mg/day of prednisone or its equivalent
- steroids as premedication for hypersensitivity reactions (e.g., computer tomography [CT] scan premedication)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Elnaz Ghalechi, 713-500-4895, Elnaz.RezaeiGhalechi@uth.tmc.edu
Umer Soomro, (713) 500-6919, Umer.T.Soomro@uth.tmc.edu
About this study
Official title: Endoscopic Ultrasound Radiofrequency Ablation and Immunotherapy Pembrolizumab for Locally Advanced Unresectable and Metastatic Pancreatic Duct Adenocarcinoma; a Phase II Trial PANcreas CAncer RaDIofrequeNcy AbLation
The purpose of this study is to perform a pilot phase II trial to evaluate the safety and efficacy of combined EUS-RFA, chemotherapy, and systemic immunotherapy (pembrolizumab) for the treatment of locally advanced unresectable and metastatic Pancreatic ductal adenocarcinoma (mPDAC).
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Being tested
- Neoadjuvant Chemotherapy (NAC), Immunotherapy (pembrolizumab), Endoscopic ultrasound (EUS)-guided radiofrequency ablation (RFA)
- Keywords
- metastatic cancer, chemotherapy, systemic immunotherapy, pembrolizumab, neoplasms, Endoscopic Ultrasound Radiofrequency ablation (EUS-RFA)
- Medical subject headings
- Neoplasm Metastasis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant Chemotherapy (NAC)Drug
Participant will undergo 8 weeks of NAC (treating physician's choice). Possible regimens are either mFOLFIRINOX or NALIRIFOX or Gemcitabine Nab-Paclitaxel ± Cisplatin (GA+/-Cisplatin) or Capecitabine (Xeloda).
Immunotherapy (pembrolizumab)Drug
2-12 weeks after initial chemotherapy and after the first EUS-RFA treatment, patients will receive 400 mg every 6 weeks of pembrolizumab via infusion. Participants will be administered standard of care chemotherapy and pembrolizumab every 6 weeks.
Endoscopic ultrasound (EUS)-guided radiofrequency ablation (RFA)Device
After 2-12 weeks of chemotherapy, patients will undergo EUS-RFA treatment 1 session every 6 weeks. Each RFA treatment will be for up to 5 cycles at 30W for 20 seconds or until there is an increase in measured impedance. After the 5th EUS-RFA, if there is clinical benefit, then patients will continue with EUS-RFA treatments until no active tumor is seen. During each session, the therapeutic gastroenterologist will evaluate if there is any tumor to undergo RFA. If no active tumor seen, then will abort RFA
| Study group | Role | What they receive |
|---|---|---|
| Standard of care chemotherapy + immunotherapy + EUS-RFA | Experimental | Not described Receives: Drug: Neoadjuvant Chemotherapy (NAC); Drug: Immunotherapy (pembrolizumab); Device: Endoscopic ultrasound (EUS)-guided radiofrequency ablation (RFA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy as assessed by the Overall response rate using RECIST v1.1 guidelines
(ORR) is defined as proportion of patients with complete response (CR) or partial response (PR)
Measured: From date of diagnosis to the initial date of first documented progression or date of death from any cause, whichever comes first, assessed up to 12 months.
Secondary outcomes (7)
Incidence of adverse events (AEs)
Measured: From the date of the initiation of study treatment until 30 days after the last dose of study treatment, withdrawal of consent, or study termination
Incidence of serious adverse events (SAEs)
Measured: From the date of the initiation of study treatment until 30 days after the last dose of study treatment, withdrawal of consent, or study termination
Duration of response (DOR)
DOR is defined as elapsed time between date of documented response (CR or PR) and date of progression or date of death from any cause.
Measured: Every 8 weeks from the time of enrollment to the date of death due to any causes for up to 5 years
Progression-free survival (PFS)
Progression-free survival (PFS) is defined as elapsed time between start date of treatment and date of progression or date of death from any cause.
Measured: Every 8 weeks from the time of enrollment to the date of death due to any causes for up to 5 years
Overall survival (OS)
Overall survival (OS) is defined as elapsed time between start date of treatment and date of death from any cause.
Measured: Every 8 weeks from the time of enrollment to the date of death due to any causes for up to 5 years
Local (distant) recurrence rate
Local (distant) recurrence rate is defined as incidence rate of local (distant) recurrence
Measured: Every 8 weeks from the time of enrollment to the date of death due to any causes for up to 5 years
Local (distant) recurrence time
Local (distant) recurrence time is defined as the elapsed time between start date of treatment and date of the first local (distant) recurrence.
Measured: Every 8 weeks from the time of enrollment to the date of death due to any causes for up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start26 Mar 2025
- Primary completion20 Jan 2028 (estimated)
- Study completion20 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 24 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Putao Cen, The University of Texas Health Science Center, Houston
- Investigators
- Putao Cen, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06831136
- Sponsor's protocol ID
- HSC-MS-24-0437
- Acronym
- PANCARDINAL-2
- Status last verified
- Oct 2026
- First submitted
- 16 Jan 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Ultrasound Radiofrequency Ablation and Immunotherapy Pembrolizumab for Locally Advanced Unresectable and Metastatic Pancreatic Duct Adenocarcinoma; a Phase II Trial PANcreas CAncer RaDIofrequeNcy AbLation
- ClinicalTrials.gov ID
- NCT06831136
- Acronym / sponsor ID
- PANCARDINAL-2 / HSC-MS-24-0437
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Keywords
- metastatic cancer, chemotherapy, systemic immunotherapy, pembrolizumab, neoplasms, Endoscopic Ultrasound Radiofrequency ablation (EUS-RFA)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 26 Mar 2025 (actual)
- Primary completion
- 20 Jan 2028 (estimated)
- Study completion
- 20 Jan 2030 (estimated)
- First posted
- 17 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to perform a pilot phase II trial to evaluate the safety and efficacy of combined EUS-RFA, chemotherapy, and systemic immunotherapy (pembrolizumab) for the treatment of locally advanced unresectable and metastatic Pancreatic ductal adenocarcinoma (mPDAC).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard of care chemotherapy + immunotherapy + EUS-RFA | Experimental | Drug: Neoadjuvant Chemotherapy (NAC), Drug: Immunotherapy (pembrolizumab), Device: Endoscopic ultrasound (EUS)-guided radiofrequency ablation (RFA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Is willing and able to comply with the protocol for the duration of the study,including undergoing treatment and scheduled visits and examinations, including follow-up
- Biopsy-proven locally advanced unresectable or metastatic PDAC
- Mental capacity to provide informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
- Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
- At least one measurable metastatic lesion on axial imaging per Response Evaluation Criteria in Solid Tumors (RECIST) v1.
Key exclusion criteria (27 listed)
- No telephone number and permanent street address
- Pregnant or breastfeeding patients; or is a male or female patient of reproductive potential who is not willing to employ effective birth control from time of screening to 90 days after the last dose
- Inmates or prisoners
- Unable to provide informed consent
- Resectable, borderline resectable PDAC.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neoadjuvant Chemotherapy (NAC)Participant will undergo 8 weeks of NAC (treating physician's choice). Possible regimens are either mFOLFIRINOX or NALIRIFOX or Gemcitabine Nab-Paclitaxel ± Cisplatin (GA+/-Cisplatin) or Capecitabine (Xeloda). | Drug | Standard of care chemotherapy + immunotherapy + EUS-RFA |
| Immunotherapy (pembrolizumab)2-12 weeks after initial chemotherapy and after the first EUS-RFA treatment, patients will receive 400 mg every 6 weeks of pembrolizumab via infusion. Participants will be administered standard of care chemotherapy and pembrolizumab every 6 weeks. | Drug | Standard of care chemotherapy + immunotherapy + EUS-RFA |
| Endoscopic ultrasound (EUS)-guided radiofrequency ablation (RFA)After 2-12 weeks of chemotherapy, patients will undergo EUS-RFA treatment 1 session every 6 weeks. Each RFA treatment will be for up to 5 cycles at 30W for 20 seconds or until there is an increase in measured impedance. After the 5th EUS-RFA, if there is clinical benefit, then patients will continue with EUS-RFA treatments until no active tumor is seen. During each session, the therapeutic gastroenterologist will evaluate if there is any tumor to undergo RFA. If no active tumor seen, then will abort RFA | Device | Standard of care chemotherapy + immunotherapy + EUS-RFA |
Primary outcome
Efficacy as assessed by the Overall response rate using RECIST v1.1 guidelines
Time frame: From date of diagnosis to the initial date of first documented progression or date of death from any cause, whichever comes first, assessed up to 12 months.
(ORR) is defined as proportion of patients with complete response (CR) or partial response (PR)
7 secondary outcomes
Incidence of adverse events (AEs)
Time frame: From the date of the initiation of study treatment until 30 days after the last dose of study treatment, withdrawal of consent, or study termination
Incidence of serious adverse events (SAEs)
Time frame: From the date of the initiation of study treatment until 30 days after the last dose of study treatment, withdrawal of consent, or study termination
Duration of response (DOR)
Time frame: Every 8 weeks from the time of enrollment to the date of death due to any causes for up to 5 years
Progression-free survival (PFS)
Time frame: Every 8 weeks from the time of enrollment to the date of death due to any causes for up to 5 years
Overall survival (OS)
Time frame: Every 8 weeks from the time of enrollment to the date of death due to any causes for up to 5 years
Local (distant) recurrence rate
Time frame: Every 8 weeks from the time of enrollment to the date of death due to any causes for up to 5 years
Local (distant) recurrence time
Time frame: Every 8 weeks from the time of enrollment to the date of death due to any causes for up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Putao Cen principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Neoadjuvant Chemotherapy (NAC), Immunotherapy (pembrolizumab) and Endoscopic ultrasound (EUS)-guided radiofrequency ablation (RFA) in people with Pancreatic Ductal Adenocarcinoma, 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 20 inclusion and 27 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 8 Oct 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 Elnaz Ghalechi (713-500-4895, Elnaz.RezaeiGhalechi@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy as assessed by the Overall response rate using RECIST v1.1 guidelines (time frame: From date of diagnosis to the initial date of first documented progression or date of death from any cause, whichever comes first, assessed up to 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2026.