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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Chicago

About this trial

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 criteria

Qualifiers

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).

leukocytes ≥3,000/mcL

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Cisplatin
  • Mitomycin

Treatment groups

21 Participants
are divided into 1 treatment group

Locations

1
University of Chicago60637, ChicagoIllinois, United States

Sponsors and collaborators

University of Chicago

Lead sponsor