Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT04107077

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

Led by University of Chicago · Updated on 2025-10-07

21

Participants Needed

1

Research Sites

37 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with confirmed gastric cancer with peritoneal metastases and/or positive peritoneal cytology who have completed systemic chemotherapy for 2 to 4 months
  • Age 18 years or older
  • ECOG performance status of 2 or better (Karnofsky 60% or higher)
  • Adequate organ and marrow function including leukocytes ≥3,000/mcL, absolute neutrophil count ≥1,500/mcL, platelets ≥100,000/mcL, total bilirubin within normal limits, AST/ALT ≤3 times normal, creatinine within normal limits or GFR ≥50 mL/min/1.73 m²
  • HIV-infected patients on effective therapy with undetectable viral load within 6 months
  • Patients with controlled hepatitis B or cured hepatitis C infection
  • Patients with prior or concurrent malignancies that do not interfere with study assessments
  • Cardiac function class 2B or better by New York Heart Association criteria
  • Expected survival greater than 3 months
  • Women of child-bearing potential and men must agree to use effective contraception during and after the study
  • Ability to understand and sign informed consent
Not Eligible

You will not qualify if you...

  • Presence of another untreated cancer (except basal cell skin cancer) within the last 5 years
  • Metastases beyond loco-regional lymph nodes and peritoneum (e.g., liver, lungs, bone, brain)
  • Unresolved toxicities greater than Grade 1 from prior anti-cancer therapy, except alopecia
  • Use of other investigational agents
  • Allergic reactions to cisplatin or Mitomycin C or similar compounds
  • Uncontrolled illness
  • Psychiatric or social conditions limiting study compliance
  • Pregnant or breastfeeding women due to potential risks of cisplatin and Mitomycin C

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Chicago

Chicago, Illinois, United States, 60637

Actively Recruiting

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Research Team

C

Cancer Clinical Trials Office

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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