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Phase II Study of the Effects of Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Patients With Advanced Gastric Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Phase II Study of the Effects of Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Patients With Advanced Gastric Cancer

A Phase IIa Study of Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) and PD-L1 Expression in Gastric Cancer With Peritoneal Metastases

NCT04107077•University of Chicago

View on ClinicalTrials.gov

Summary

To assess if PD-L1 expression can be upregulated in peritoneal metastases from gastric cancer after the administration of HIPEC with greater frequency compared to systemic chemotherapy alone

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.
•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.
•ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).
•Patients must have adequate organ and marrow function as defined below:
•* leukocytes ≥3,000/mcL
•* absolute neutrophil count ≥1,500/mcL
•* platelets ≥100,000/mcL
•* total bilirubin ≤ institutional upper limit of normal (ULN)
•* AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN
•* creatinine ≤ institutional ULN OR
+8 more criteria

Exclusion Criteria

•Patients with coexistence of another untreated malignant neoplasm other than basal cell carcinoma of the skin within the last five years.
•Sites of metastases other than loco-regional lymph nodes and peritoneum (ex. Visceral metastases such as liver, lungs, bone, brain).
•Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1) with the exception of alopecia.
•Patients who are receiving any other investigational agents.
•History of allergic reactions attributed to compounds of similar chemical or biologic composition to cisplatin and Mitomycin C.
•Patients with uncontrolled intercurrent illness.
•Patients with psychiatric illness/social situations that would limit compliance with study requirements.
•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.

Locations (1)

University of Chicago

Chicago, Illinois, United States

Key Dates

Start Date

September 9, 2025

Primary Completion Date

June 1, 2026

Completion Date

June 1, 2026

Last Updated

October 7, 2025

Enrollment

ESTIMATED participants

Conditions

Gastric CancerPeritoneal Carcinomatosis

Interventions

Cisplatin

DRUG

Mitomycin

DRUG

Contacts

Cancer Clinical Trials Office

CONTACT

1-855-702-8222 cancerclinicaltrials@bsd.uchicago.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 7, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Phase II Study of the Effects of Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Patients With Advanced Gastric Cancer

Inclusion Criteria

Exclusion Criteria

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