Phase II Study on the Effects of Heated Chemotherapy During Laparoscopic Surgery for Advanced Stomach Cancer

Sponsor: University of Chicago

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04107077

This clinical trial is exploring whether a heated chemotherapy treatment applied directly to the abdomen during surgery can increase the effectiveness of treatment for patients with advanced stomach cancer, compared to standard chemotherapy alone.

Patient Parameters

Program Overview

The purpose of this study is to find out if using a heated chemotherapy treatment, known as HIPEC, during laparoscopic surgery can increase the expression of a protein called PD-L1 in cancer that has spread to the abdomen from the stomach. This could potentially make the cancer more responsive to treatment compared to using standard chemotherapy alone.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with advanced stomach cancer that has spread to the abdomen, and have completed 2 to 4 months of prior chemotherapy.
  • Aged 18 years or older.
  • In good general health with a performance status score of 2 or less, meaning able to carry out light work or more.
  • Have adequate blood cell counts and organ function, including:
    • White blood cells of at least 3,000/mcL.
    • Neutrophil count of at least 1,500/mcL.
    • Platelet count of at least 100,000/mcL.
    • Normal liver and kidney function as indicated by specific blood tests.
  • HIV-positive patients can participate if they are on effective treatment with an undetectable viral load.
  • Patients with hepatitis B or C can participate if their viral load is undetectable or they have been cured.
  • No other cancers that could interfere with the study.
  • Heart function must be stable, with a classification of 2B or better.
  • Expected to live for more than 3 months.
  • Women and men must agree to use effective birth control during the study and for a period after the study ends.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Have another untreated cancer, except for certain skin cancers, within the last five years.
  • Cancer has spread to organs like the liver, lungs, bones, or brain.
  • Have not fully recovered from side effects of previous cancer treatments, except for hair loss.
  • Currently taking other experimental drugs.
  • Have allergies to similar drugs used in the study.
  • Have uncontrolled illnesses or psychiatric conditions that could affect participation.
  • Pregnant or breastfeeding women cannot participate due to potential risks to the baby.

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