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Endoscopic Ultrasound Radiofrequency Ablation and Immunotherapy Pembrolizumab for Locally Advanced Unresectable and Metastatic Pancreatic Duct Adenocarcinoma

ConditionPancreatic Ductal Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Texas Health Science Center, Houston

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: Standard of care chemotherapy + immunotherapy + EUS-RFAExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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)

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.

Secondary outcomes

1

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
2

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
3

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.

Time frame
Every 8 weeks from the time of enrollment to the date of death due to any causes for up to 5 years
4

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.

Time frame
Every 8 weeks from the time of enrollment to the date of death due to any causes for up to 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Health Science Center, Houston

Lead sponsor

Source ClinicalTrials.gov
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