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Alkylating agents

HIPEC for Advanced Stomach Cancer

Phase 2
Recruiting
Led By Kiran Turaga, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18 years. Because no dosing or adverse event data are currently available on the use of HIPEC for GC/PM in patients under 18 years of age, children are excluded from this study, but will be eligible for future pediatric trials
Patients with histologically confirmed GC/PM only and/or positive peritoneal cytology, who have completed prior systemic chemotherapy for a minimum of 2 to 4 months duration
Must not have
History of allergic reactions attributed to compounds of similar chemical or biologic composition to cisplatin and Mitomycin C
Pregnant women are excluded from this study because cisplatin and Mitomycin C are class D agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with cisplatin and Mitomycin C, breastfeeding should be discontinued if the mother is treated with cisplatin and Mitomycin C.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at whether a certain type of chemotherapy can help to increase the expression of a protein called PD-L1 in stomach cancer that has spread to the abdomen.

Who is the study for?
This trial is for adults over 18 with advanced gastric cancer that has spread to the lining of the abdomen. They must have completed at least 2-4 months of chemotherapy, have good kidney and liver function, not be severely ill from other causes, and cannot be pregnant or breastfeeding. People with HIV or hepatitis are eligible if their viral loads are undetectable.
What is being tested?
The study tests whether heating chemotherapy drugs (Cisplatin and Mitomycin) inside the abdomen after surgery can make immune markers go up in stomach cancer cells more than just giving chemo through a vein. This technique is called HIPEC.
What are the potential side effects?
HIPEC treatment may cause side effects like kidney damage, blood cell count changes leading to increased infection risk or bleeding problems, fatigue, nausea, vomiting, and potential harm to an unborn child.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have stomach or peritoneal cancer and finished chemo for 2-4 months.
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I had hepatitis C but have been treated and cured, or I am currently being treated with an undetectable viral load.
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My hepatitis B virus load is undetectable with treatment.
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I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am allergic to medications similar to cisplatin or Mitomycin C.
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I am not pregnant or breastfeeding.
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My cancer has spread to organs like the liver, lungs, bone, or brain.
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I do not have any unmanaged ongoing illnesses.
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I have not had any cancer other than skin cancer in the last 5 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The PD-L1 expression can be upregulated after administration of HIPEC with greater frequency
Secondary study objectives
Overall Survival Rate
Perioperative morbidity at 30 days
Perioperative mortality at 30 days
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Drug Administration PeriodExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mitomycin
2009
Completed Phase 3
~410
Cisplatin
2013
Completed Phase 3
~3120

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
1,056 Previous Clinical Trials
760,888 Total Patients Enrolled
Kiran Turaga, MDPrincipal InvestigatorUniversity of Chicago
4 Previous Clinical Trials
352 Total Patients Enrolled
Oliver S Eng, MDPrincipal InvestigatorUniversity of Chicago

Media Library

Cisplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT04107077 — Phase 2
Stomach Cancer Research Study Groups: Drug Administration Period
Stomach Cancer Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT04107077 — Phase 2
Cisplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04107077 — Phase 2
~14 spots leftby Jun 2026
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