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

A Phase II Single Arm Study of Combined Systemic and Intraperitoneal Chemotherapy for Synchronous Gastric and/or Gastroesophageal Peritoneal Carcinomatosis

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Synchronous Gastric Peritoneal Carcinomatosis; Gastroesophageal Peritoneal Carcinomatosis
• Intervention / Treatment: Drug: Cisplatin; Drug: Mitomycin C

Detailed Description

Patients with peritoneal carcinomatosis from gastric cancer (GPC) have dismal oncologic outcomes, with median survival duration of 6-12 months and 2-year overall survival rate of < 10%. Despite advancements in systemic therapy, survival remains poor and most patients succumb to the disease within 4-11 months following diagnosis. Therefore, there is a substantial need for novel treatment strategies to improve oncologic outcomes in GPC. The primary intervention is the addition of iterative laparoscopic HIPEC to the ongoing standard systemic chemotherapy regimen (or at least the backbone regimen), based on discussion with their treating medical oncologist. Laparoscopic HIPEC will be performed using a combination of cisplatin (100 mg/m2) 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. Systemic chemotherapy will be administered every two weeks while laparoscopic HIPEC procedures will be performed every 6 weeks in place of the scheduled biweekly systemic therapy cycle. The trial will include a maximum of 3 laparoscopic HIPEC procedures.

• Study Type: Interventional
• Enrollment (Estimated): 22
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Debra Diecks, RN, BSN; Phone Number: 412-623-8364; Email: diecksda@upmc.edu
• Study Contact Backup: Name: Cole Stacy, RN, BSN; Phone Number: 878-261-6872; Email: colesl2@upmc.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • UPMC Hillman Cancer Center
      • Contact: Debra Diecks, RN, BSN; Phone Number: 412-623-8364; Email: diecksda@upmc.edu
      • Contact: Cole Stacy, RN, BSN; Phone Number: 878-261-6872; Email: colesl2@upmc.edu
      • Principal Investigator: Haroon Choudry, MBBS, FACS
      • Sub-Investigator: Samer AlMasri, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hyperthermic intraperitoneal chemotherapy (HIPEC); 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; Cisplatin interferes with DNA replication, which kills the fastest proliferating cells.; Drug: Mitomycin C; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment-related Adverse Events	Frequency and severity (grade) of adverse events (AE) related to study treatment per CTCAE v5.0.	Up to 5 years
Progression-free Survival (PFS)	Median time from first laparoscopic HIPEC procedure to progression or death from any cause. 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.	Up to 5 years
Overall Survival (OS)	Median time from first laparoscopic HIPEC procedure to death from any cause.	Up to 8 years
Objective Response Rate (ORR)	ORR is defined as the proportion of patients achieving a complete response (CR) or partial response (PR). Per RECIST v1.1, Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to <10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.	Up to 5 years
Objective Response Rate (ORR) Peritoneal Cancer Index (PCI)	ORR per Peritoneal Cancer Index (PCI) score extracted from diagnostic laparoscopy procedures (in all patients), defined as the proportion of patients who achieve a reduction in PCI score. This scoring system quantifies the extent of peritoneal metastases in patients with abdominal cancers. It ranges from 0 to max score of 39, with lower scores indicating less disease burden and better surgical outcomes. The abdomen is divided into 13 regions, each scored from 0 to 3 based on the size and extent of tumor involvement. The total score is the sum of these individual scores, providing a clear picture of the disease's spread.	Up to 5 years
EQ-5D-5L scores	The EQ-5D-5L self-administered questionnaire captures health status across five key dimensions: Mobility: Ability to walk about; Self-Care: Ability to wash or dress oneself; Usual Activities: Ability to perform usual activities (work, study, housework, family, or leisure activities); Pain/Discomfort: Level of pain or discomfort experienced; Anxiety/Depression: Level of anxiety or depression experienced. A 5-level/point scale is used: 1: No problems, 2: Slight problems, 3: Moderate problems, 4: Severe problems, 5: Extreme problems. Scores from each key dimension are added to yield a total score ranging from 5 to 25. Higher scores indicate worse health status. A Visual Analogue Scale (VAS) is also included: Patients rate their overall health on a scale from 0 (worst imaginable health) to 100 (best imaginable health).	Up to 5 years
Rate of Cytoreductive Surgery (CRS)/HIPEC	Percentage of patients with unresectable locoregional disease prior to enrollment who undergo CRS/HIPEC.	Up to 5 years

Collaborators and Investigators

• Sponsor: Mohammad Haroon Asif Choudry
• Collaborators: Dr. Samer AlMasri, MD
• Investigators: Principal Investigator: Haroon Choudry, MBBS, FACS, UPMC Hillman Cancer Center

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2026
• Primary Completion (Estimated): April 30, 2030
• Study Completion (Estimated): April 30, 2034

Study Registration Dates

• First Submitted: March 9, 2026
• First Submitted That Met QC Criteria: March 11, 2026
• First Posted (Actual): March 16, 2026

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
• Additional Relevant MeSH Terms: Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indoles; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Platinum Compounds; Quinones; Azirines; Mitomycins; Indolequinones; Cisplatin; Mitomycin
• Other Study ID Numbers: HCC 25-124

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No