Your session is about to expire
← 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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
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 moreTrial 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
1,012 Previous Clinical Trials
734,049 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have another cancer, but it won't affect this trial's treatment.I am allergic to medications similar to cisplatin or Mitomycin C.You cannot be part of any other experimental treatments or studies at the same time.I am not pregnant or breastfeeding.My heart function is classified as class 2B or better according to NYHA.I have recovered from side effects of previous cancer treatments, except for hair loss.My cancer has spread to organs like the liver, lungs, bone, or brain.I do not have any unmanaged ongoing illnesses.I am 18 years old or older.I have stomach or peritoneal cancer and finished chemo for 2-4 months.Your doctor expects you to live for more than 3 months.My kidney function is within the safe range for the trial.I had hepatitis C but have been treated and cured, or I am currently being treated with an undetectable viral load.I agree to use birth control during and up to 4 months after the study.My organs and bone marrow are working well.I am HIV positive, on treatment, and my viral load has been undetectable for the last 6 months.My hepatitis B virus load is undetectable with treatment.I can take care of myself but might not be able to do heavy physical work.I have not had any cancer other than skin cancer in the last 5 years.
Research Study Groups:
This trial has the following groups:- Group 1: Drug Administration Period
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger