Study Comparing Intra-arterial Gemcitabine to IV Gemcitabine and Nab-Paclitaxel After Radiotherapy for Locally Advanced Pancreatic Cancer

Sponsor: RenovoRx

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03257033

Provider View

This clinical trial is comparing two different ways of giving chemotherapy to patients with locally advanced pancreatic cancer that cannot be removed by surgery. The study aims to find out if delivering chemotherapy directly into the arteries is more effective than the standard intravenous method.

Patient Parameters

Program Overview

This study is testing two different methods of delivering chemotherapy to patients with locally advanced pancreatic cancer that cannot be surgically removed. All participants will first receive a combination of chemotherapy drugs, gemcitabine and nab-paclitaxel, along with radiation therapy for about four months. After this initial treatment, participants will be randomly assigned to either continue with the standard intravenous chemotherapy or switch to a method where gemcitabine is delivered directly into the arteries. The study will last up to 16 weeks, with follow-up treatments and monitoring for up to five years to assess survival.

Description

Participants in this study will first receive a combination of chemotherapy drugs, gemcitabine and nab-paclitaxel, along with radiation therapy for approximately four months. After this initial treatment, those who are eligible will be randomly assigned to one of two groups. One group will continue receiving the standard intravenous chemotherapy with gemcitabine and nab-paclitaxel, while the other group will receive gemcitabine delivered directly into the arteries. This phase of the study will last up to 16 weeks or until the cancer progresses. After this period, both groups may continue with either intravenous gemcitabine and nab-paclitaxel or switch to an oral chemotherapy drug, capecitabine, based on the doctor's decision. Participants will be monitored for survival for up to five years.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with pancreatic cancer that cannot be surgically removed, confirmed by lab tests.
  • Cancer diagnosis made within six weeks of joining the study.
  • Cancer must be locally advanced and confirmed by scans.
  • Good overall health with a performance status score of 0 or 1.
  • Aged 18 years or older.
  • Adequate blood and organ function as shown by specific lab tests.
  • Life expectancy of more than 12 weeks.
  • Negative pregnancy test for women who can have children, and agreement to use effective birth control during and after treatment.
  • Willing to provide written consent and participate in the study for at least eight months.

Exclusion Criteria

  • Previous treatment for pancreatic cancer or more than one cycle of the current chemotherapy regimen.
  • Evidence of cancer spread to other parts of the body or another active cancer within the past year.
  • Unable or unwilling to start the randomized treatment within the specified time frame.
  • No baseline tumor imaging available.
  • Arterial anatomy unsuitable for intra-arterial chemotherapy delivery.
  • Contraindications for radiation therapy planning.
  • Known HIV infection or active viral hepatitis.
  • Severe infections or signs of infection close to the start of the study.
  • History of severe allergic reactions to the study drugs.
  • Recent anti-cancer therapy or herbal treatments intended as anti-cancer therapy.
  • Uncontrolled seizures or significant heart disease.
  • Other severe health conditions that make participation difficult.
  • Recent major surgery or certain medical procedures.
  • Women who are breastfeeding.
  • Participants not agreeing to use effective contraception.
  • Participation in another clinical trial or investigational treatment recently.
  • Social or psychiatric issues that limit compliance with study requirements.

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