Is NCT06831136 recruiting in Houston, TX?

Yes, NCT06831136 is currently recruiting participants at its Houston, TX location. This pancreatic ductal adenocarcinoma clinical trial is actively enrolling qualified participants.

How do I join the pancreatic ductal adenocarcinoma clinical trial in Houston?

To join this clinical trial in Houston, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Houston clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Pancreatic Ductal Adenocarcinoma Clinical Trial in Houston, TX

About This Pancreatic Ductal Adenocarcinoma Study in Houston

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).

Sponsor: The University of Texas Health Science Center, Houston

Who Can Participate

Inclusion Criteria

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

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 stable disease before study entry. Note: Imaging done outside the site will need to be reviewed for a 2nd opinion to confirm stable disease. i. 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. c. 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 a. 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.

Exclusion Criteria

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

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)

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Houston?

Yes, this clinical trial (NCT06831136) has an active research site in Houston, TX that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Pancreatic Ductal Adenocarcinoma Treatment Options in Houston, TX

If you're searching for pancreatic ductal adenocarcinoma treatment options in Houston, TX, this clinical trial (NCT06831136) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Houston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced pancreatic ductal adenocarcinoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all pancreatic ductal adenocarcinoma clinical trials near you to find additional studies recruiting in your area.

Pancreatic Ductal Adenocarcinoma Clinical Trial in Houston, TX

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