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

NCT04107077 | Recruiting Phase 2 FDA Drug

• 1 other identifier: IRB19-0160
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Gastric Cancer; Peritoneal Carcinomatosis

Outcome Measures

Primary Outcomes (1)

• The PD-L1 expression can be upregulated after administration of HIPEC with greater frequency

  To examine 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. PD-L1 expression will be measured quantitatively by combined positive score (CPS), with upregulation defined as an quantitative increase in PD-L1 expression via CPS compared to the previously measured timepoint (baseline CPS of 0).

  2 years

Secondary Outcomes (5)

• The rate of conversion to resectability with repeated interval laparoscopic HIPEC

  2 years

• To quantitatively assess peritoneal cancer index (PCI) change with repeated interval laparoscopic HIPEC.

  2 years

• Overall Survival Rate

  2 years

• Perioperative morbidity at 30 days

  30 days

• Perioperative mortality at 30 days

  30 days

Study Arms (1)

Drug Administration Period

EXPERIMENTAL

Drug: Cisplatin; Drug: Mitomycin

Interventions

Cisplatin DRUG

Laparoscopic HIPEC will be performed at a maximum of two (2) times spaced approximately 6 weeks apart. The dosing of the drugs will be the same during each administration but adjusted if needed based on lab work. The typical dosages are 200mg of Cisplatin

Drug Administration Period

Mitomycin DRUG

Laparoscopic HIPEC will be performed at a maximum of two (2) times spaced approximately 6 weeks apart. The dosing of the drugs will be the same during each administration but adjusted if needed based on lab work. The typical dosages are 30mg of Mitomycin C.

Drug Administration Period

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• glomerular filtration rate (GFR) ≥50 mL/min/1.73 m2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m2 (see Appendix B).
• Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
• For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
• Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
• Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms; Peritoneal Neoplasms

Interventions

Cisplatin; Mitomycin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Abdominal Neoplasms; Peritoneal Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Ardaman Shergill

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cancer Clinical Trials Office

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: September 27, 2019
• Study Start: September 9, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: October 7, 2025

Record last verified: 2025-09

Locations

US (1)