Study on Gemcitabine, Cisplatin, and Nab-Paclitaxel Before Surgery for Treating Resectable or Borderline Resectable Pancreatic Cancer

Sponsor: Emory University

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06423326

Provider View

This clinical trial is exploring how well a combination of chemotherapy drugs—gemcitabine, cisplatin, and nab-paclitaxel—works when given before surgery to treat pancreatic cancer that can be removed or is almost removable by surgery.

Patient Parameters

Program Overview

The purpose of this study is to see if using the chemotherapy drugs gemcitabine, cisplatin, and nab-paclitaxel before surgery can help control pancreatic cancer that can be surgically removed or is close to being removable. These drugs work by stopping cancer cells from growing and dividing, potentially killing them. The study aims to find out if this treatment approach can improve survival rates compared to having surgery first.

Description

The main goal of this study is to determine how well the combination of gemcitabine, cisplatin, and nab-paclitaxel works in shrinking pancreatic tumors before surgery. Researchers will also look at how safe and feasible this treatment is for patients.

Patients will receive the chemotherapy drugs through an IV on specific days of each treatment cycle, which lasts 28 days. This treatment will be repeated for up to four cycles unless the cancer progresses or side effects become too severe. If the cancer is stable or has responded well, patients will then undergo surgery to remove the tumor.

Throughout the study, patients will have biopsies, blood tests, and imaging scans to monitor their response to the treatment. After completing the study treatment, patients will have follow-up visits every 3-4 months for up to two years to check on their health and any signs of cancer returning.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with pancreatic cancer that can be removed or is almost removable by surgery.
  • Cancer must meet specific criteria based on imaging tests to determine if it is resectable or borderline resectable.
  • No spread of cancer beyond the pancreas.
  • Adults aged 18 and older.
  • Able to understand and agree to the study requirements.
  • Good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Adequate blood cell counts and organ function as determined by specific blood tests.
  • Not pregnant or breastfeeding, and willing to use effective contraception during the study and for a specified time after treatment.
  • Men must agree to use condoms during sexual activity with women of childbearing potential during the study and for six months after treatment.

Exclusion Criteria

  • Have moderate or severe nerve damage affecting daily activities.
  • Have serious or uncontrolled medical conditions, such as recent heart attack, unstable heart rhythm, severe heart failure, uncontrolled diabetes, or active infections.
  • Pregnant or breastfeeding.
  • Have untreated brain disease, except for treated brain metastases that are stable.
  • Have had another untreated cancer within the past five years, except for certain skin cancers or in situ carcinomas.
  • Allergic to any of the study drugs.
  • Current abuse of alcohol or illegal drugs.
  • Unable or unwilling to sign the informed consent form.

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