← Back to Search

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am 18 years old or older.
Select...
I have stomach or peritoneal cancer and finished chemo for 2-4 months.
Select...
I had hepatitis C but have been treated and cured, or I am currently being treated with an undetectable viral load.
Select...
My hepatitis B virus load is undetectable with treatment.
Select...
I can take care of myself but might not be able to do heavy physical work.

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

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

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
~1940

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
1,010 Previous Clinical Trials
733,923 Total Patients Enrolled
Kiran Turaga, MDPrincipal InvestigatorUniversity of Chicago
4 Previous Clinical Trials
400 Total Patients Enrolled
Oliver S Eng, MDPrincipal InvestigatorUniversity of Chicago

Media Library

Cisplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT04107077 — Phase 2
Peritoneal Carcinomatosis Research Study Groups: Drug Administration Period
Peritoneal Carcinomatosis 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Mitomycin been cleared by the FDA?

"There is some data supporting the safety of Mitomycin, but none indicating that it is an effective treatment, so it received a score of 2."

Answered by AI

How many people are included in this research?

"Yes, that is accurate. The clinical trial's website indicates that the research is ongoing and still recruiting patients. The 21 participants are needed at a single location."

Answered by AI

What are some conditions that doctors usually treat with Mitomycin?

"Though most often used to treat head and neck carcinoma, mitomycin can also be an effective medication for cervical cancers, low-grade upper tract urothelial cancer (lg-utuc), and glaucoma."

Answered by AI

Are volunteers currently being accepted for this research?

"That is correct. The information available on clinicaltrials.gov does show that the trial is currently recruiting patients. According to the website, the study was posted on November 11th, 2019 and updated January 19th, 2022. They are looking for a total of 21 participants from 1 site."

Answered by AI

How does this new research on Mitomycin compare to other findings in the field?

"745 trials are currently underway to study Mitomycin. Of these, 292 are in Phase 3. Most of the research is conducted in Shanghai, but there are 44334 locations running studies for this treatment."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
Texas
What site did they apply to?
University of Chicago
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

Recent research and studies
clinicaltrials.govStudy
Phase II Study of the Effects of Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Patients With Advanced Gastric Cancer
2024. "Phase II Study of the Effects of Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Patients With Advanced Gastric Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04107077.
All > Peritoneal Carcinomatosis > Gastric Cancer
~0 spots leftby Jun 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top