Phase II Study on the Effects of Heated Chemotherapy During Laparoscopic Surgery for Advanced Stomach Cancer
Sponsor: University of Chicago
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
| Parameter | Options |
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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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Chicago | 60637 | Chicago | Illinois |
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