Combined Systemic and Intraperitoneal Chemotherapy for Synchronous Gastric and/or Gastroesophageal Peritoneal Carcinomatosis

NCT07475286 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: HCC 25-124
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Synchronous Gastric Peritoneal Carcinomatosis; Gastroesophageal Peritoneal Carcinomatosis

Keywords

Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

Outcome Measures

Primary Outcomes (1)

• 1-year Progression-free Survival (PFS)

  The proportion of patients alive without progression at one year from the date of the first laparoscopic HIPEC treatment. Per RECIST v1.1, Progressive Disease is defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.

  At 1 year

Secondary Outcomes (7)

• Treatment-related Adverse Events

  Up to 5 years

• Progression-free Survival (PFS)

  Up to 5 years

• Overall Survival (OS)

  Up to 8 years

• Objective Response Rate (ORR)

  Up to 5 years

• Objective Response Rate (ORR) Peritoneal Cancer Index (PCI)

  Up to 5 years

Study Arms (1)

Hyperthermic intraperitoneal chemotherapy (HIPEC)

EXPERIMENTAL

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.

Drug: Cisplatin; Drug: Mitomycin C

Interventions

Cisplatin DRUG

Cisplatin interferes with DNA replication, which kills the fastest proliferating cells.

Hyperthermic intraperitoneal chemotherapy (HIPEC)

Mitomycin C DRUG

A drug that slows down the growth of cancer cells by making them less able to create the DNA, RNA, and proteins they need to multiply.

Hyperthermic intraperitoneal chemotherapy (HIPEC)

Eligibility Criteria

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

You may qualify if:

• Histologically proven, synchronous gastric and/or gastroesophageal junction (Siewert 3) adenocarcinoma with either positive peritoneal cytology (micPC) or macroscopic carcinomatosis (macPC) (stage IV), diagnosed by imaging or laparoscopy or laparotomy.
• Patients must be 18 years of age or older at time of informed consent.
• ECOG performance status of ≤ 2\*
• \*Note: ECOG PS of 2 is allowed only if debilitation is caused by the gastric cancer and not by other comorbidities.
• Must have normal organ and marrow function following completion of 4-6 months systemic therapy and prior to enrollment as assessed on basic laboratory tests:
• Hemoglobin ≥ 8.0 g/dL Leukocytes ≥ 3,000/mcL Absolute neutrophil count ≥ 1,500/mcL Platelet count ≥ 100,000/mcL Total bilirubin \< 2mg/dl AST (SGOT) ≤ 2.5 X institutional upper limit of normal (ULN) ALT (SGPT) ≤ 2.5 X institutional ULN Serum creatinine within normal institutional limits
• Patient should have a life expectancy of \>6 months per the discretion of the treating surgical oncologist and/or medical oncologist in relation to comorbidities and volume of disease.
• Patients must have received at least 4 months (maximum 6 months) of 1st or 2nd line systemic therapy at the discretion of the treating medical oncologist and/or surgical oncologist and exhibit no evidence of extraperitoneal disease progression prior to enrollment.
• Patients with stable oligometastatic liver only metastasis (≤ 3 lesions, each \< 3 cm in maximum dimension), ovarian-only metastases, or lung-only metastases (≤ 5 lesions, each \< 1 cm) that are amenable to curative intent surgical resection and/or thermal ablation and/or SBRT will be eligible for enrollment.
• Sexually active fertile subjects and their partners must agree to use highly effective method of contraception prior to study entry and during the course of the study. An additional contraceptive method, such as a barrier method (e.g., condom), is required. In addition, men must agree not to donate sperm and women must agree not to donate eggs (ova, oocyte) for the purpose of reproduction during these same periods.
• Female subjects of childbearing potential must not be pregnant or breastfeeding at screening. Female subjects are considered to be of childbearing potential unless one of the following criteria is met:
• Permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman \> 45 years-of-age in the absence of other biological or physiological causes.) Note: Documentation may include review of medical records, medical examination, or medical history interview by study site staff.
• Must have the ability to understand and the willingness to sign a written informed consent document.
• Must be able to read and write in English.

You may not qualify if:

• Patients with MSI-H tumors, dMMR, TMB \> 30, CPS \> 40, POL-E mutation, Claudin 18.2 positive tumors, BRAFV600E, RET fusions, HER-2-neu (3+ on IHC) or positive on FISH will be excluded.
• Extensive retroperitoneal lymph node involvement not amenable to surgical resection during gastrectomy.
• Recurrent large or small bowel obstruction attributable to the cancer (except for gastric outlet obstruction).
• Prior abdominal surgeries that preclude safe and effective laparoscopy/laparoscopic HIPEC.
• Significant ascites requiring repeated drainage for symptomatic relief.
• Other malignancy within the preceding 3 years (except for non-melanoma skin cancer, early-stage prostate cancer, or curatively treated cervical cancer in-situ).
• Patients should have recovered to baseline from any clinically significant adverse events from prior treatment.
• Has acute or chronic active hepatitis B and C virus infection or known history of untreated hepatitis B (defined as hepatitis B surface antigen \[HBsAg\] reactive) or known active hepatitis C virus (HCV) (defined as HCV RNA \[qualitative\]) or HIV infection (see note).
• Note: No testing for Hepatitis B, Hepatitis C, or HIV is required unless mandated by local health authority or clinically indicated.
• Note: Participants with a history of HIV infection are considered eligible if CD4+ T cell counts are ≥ 350 cells/µL and the patient has had no opportunistic infections in the last 12 months.

Sponsors & Collaborators

• Mohammad Haroon Asif Choudry: lead
• Dr. Samer AlMasri, MD: collaborator

Study Sites (1)

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

MeSH Terms

Interventions

Cisplatin; Mitomycin

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

• Haroon Choudry, MBBS, FACS

  UPMC Hillman Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Debra Diecks, RN, BSN

CONTACT

412-623-8364; diecksda@upmc.edu

Stacy Cole, RN, BSN

CONTACT

878-261-6872; colesl2@upmc.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 INVESTIGATOR
• PI Title: Associate Professor of Surgery

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 16, 2026
• Study Start: June 12, 2026
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): June 30, 2034
• Last Updated: July 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)