Chemotherapy for Stomach Cancer

Overseen By Cole Stacy, RN, BSN

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Mohammad Haroon Asif Choudry

Must be taking: Systemic chemotherapy

Disqualifiers: MSI-H tumors, dMMR, TMB > 30, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 18 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial will administer laparoscopic hyperthermic intraperitoneal chemotherapy (HIPEC) to patients with peritoneal carcinomatosis from gastric cancer (GPC) who are receiving standard of care systemic chemotherapy.

Who Is on the Research Team?

Haroon Choudry, MBBS, FACS

Principal Investigator

UPMC Hillman Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

I can care for myself, and any weakness is only due to my gastric cancer.

Patient should have a life expectancy of >6 months

Sexually active fertile subjects and their partners must agree to use highly effective method of contraception

Exclusion Criteria

I have had abdominal surgeries that make laparoscopic procedures unsafe for me.

I have fluid buildup in my abdomen that needs frequent draining.

My tumor has one of several specific genetic or protein markers.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive systemic chemotherapy every two weeks and laparoscopic HIPEC every 6 weeks, with a maximum of 3 HIPEC procedures

18 weeks

Biweekly visits for systemic chemotherapy, every 6 weeks for HIPEC

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Cisplatin
• Mitomycin C

How Is the Trial Designed?

Group I: Hyperthermic intraperitoneal chemotherapy (HIPEC) Experimental Treatment 2 Interventions

Combination of cisplatin (100 mg/m\^2) and mitomycin C (30 mg total, administered in 2 divided doses of 15 mg each, 45 minutes apart) in 3-liters of normal saline perfusate at 42°C for 90 minutes, with continuous manipulation of the abdomen to ensure even distribution.

Who Is Running the Clinical Trial?

Mohammad Haroon Asif Choudry

Lead Sponsor

Dr. Samer AlMasri, MD

Collaborator