Study on Chemotherapy and Immunotherapy Before Surgery for Patients with Resectable Pancreatic Cancer

Sponsor: Baylor College of Medicine

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05132504

Provider View

This clinical trial is testing a combination of chemotherapy and immunotherapy drugs given before surgery to see if it can help control pancreatic cancer that can be surgically removed. The study aims to improve treatment outcomes for patients with this type of cancer.

Patient Parameters

Program Overview

The purpose of this study is to evaluate if using a combination of chemotherapy drugs (FOLFIRINOX) and an immunotherapy drug (Pembrolizumab) before surgery can better control pancreatic cancer that can be surgically removed. The study will involve 30 participants and will last approximately 3.5 years, with each participant receiving treatment for about 16 months.

Description

This Phase II clinical trial is exploring a treatment plan for patients with localized pancreatic cancer that can be surgically removed. The treatment involves giving patients a combination of chemotherapy (FOLFIRINOX) and immunotherapy (Pembrolizumab) before surgery, followed by additional chemotherapy and immunotherapy after surgery. The goal is to see if this approach can improve the body's immune response to the cancer and lead to better outcomes.

Participants will receive 6 cycles of FOLFIRINOX and 2 cycles of Pembrolizumab before surgery. After surgery, they will receive up to 6 cycles of 5FU-based chemotherapy and 7 more cycles of Pembrolizumab. The study will closely monitor for any side effects, and the treatment will be adjusted if necessary to ensure safety.

The study will use a specific method to monitor for any serious side effects, and if too many occur, the study may be paused to ensure participant safety. This method helps to keep the risk of serious side effects within acceptable limits.

Eligibility Criteria

Inclusion Criteria

  • Be 18 years or older with a confirmed diagnosis of localized pancreatic cancer that can potentially be removed by surgery.
  • Have a CT or MRI scan to confirm the cancer's stage and eligibility for the study.
  • No cancer spread to major arteries or distant organs.
  • Women of childbearing potential must have a negative pregnancy test before starting treatment and agree to use effective contraception.
  • Men must agree to use contraception during treatment and for a specified period after.
  • Must not have received prior chemotherapy or radiation for pancreatic cancer.
  • Have a good performance status, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Understand the study and agree to participate by signing an informed consent form.
  • Have adequate organ function as determined by specific blood tests.

Exclusion Criteria

  • Have pancreatic cancer that is borderline resectable, locally advanced, or has spread to other parts of the body.
  • Have active, uncontrolled infections.
  • Have a known HIV infection.
  • Have had major surgery within 4 weeks before joining the study.
  • Have allergies or hypersensitivity to the study drugs.
  • Have serious medical conditions that make it unsafe to receive chemotherapy or radiation.
  • Have another progressing cancer or have required treatment for another cancer within the past 2 years.
  • Have significant heart disease within the past year.
  • Be unable or unwilling to comply with study procedures.
  • Be participating in another clinical trial.
  • Have peripheral neuropathy of Grade 2 or higher.
  • Have received prior therapy with certain immune checkpoint inhibitors.
  • Have received a live vaccine within 30 days before starting the study.
  • Have a diagnosis of immunodeficiency or be on chronic immunosuppressive therapy.
  • Have active autoimmune disease requiring treatment in the past 2 years.
  • Have a history of lung disease requiring steroids.
  • Have a known history of Hepatitis B or active Hepatitis C infection.
  • Have any condition that might interfere with the study or not be in the participant's best interest.
  • Have psychiatric or substance abuse disorders that would interfere with the study.
  • Have had an organ transplant.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.