Synchronous Gastric Peritoneal CarcinomatosisPhase 2NCT07475286
Combined Systemic and Intraperitoneal Chemotherapy for Synchronous Gastric and/or Gastroesophageal Peritoneal Carcinomatosis
A Phase 2 study testing Cisplatin and Mitomycin C in people with Synchronous Gastric Peritoneal Carcinomatosis and Gastroesophageal Peritoneal Carcinomatosis, run by Mohammad Haroon Asif Choudry at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Synchronous Gastric Peritoneal Carcinomatosis, Gastroesophageal Peritoneal Carcinomatosis
- What is being tested?
- Cisplatin and Mitomycin C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2026to 30 Jun 2034
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Debra Diecks, RN, BSN, 412-623-8364, diecksda@upmc.edu
Cole Stacy, RN, BSN, 878-261-6872, colesl2@upmc.edu
About this study
Official title: 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.
Read the 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.
- Being tested
- Cisplatin, Mitomycin C
- Keywords
- Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisplatinDrug
Cisplatin interferes with DNA replication, which kills the fastest proliferating cells.
Mitomycin CDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Cisplatin; Drug: Mitomycin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 1 year
Secondary outcomes (7)
Treatment-related Adverse Events
Frequency and severity (grade) of adverse events (AE) related to study treatment per CTCAE v5.0.
Measured: 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.
Measured: Up to 5 years
Overall Survival (OS)
Median time from first laparoscopic HIPEC procedure to death from any cause.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Up to 5 years
Rate of Cytoreductive Surgery (CRS)/HIPEC
Percentage of patients with unresectable locoregional disease prior to enrollment who undergo CRS/HIPEC.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start29 Sep 2026
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Jun 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Synchronous Gastric Peritoneal CarcinomatosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohammad Haroon Asif Choudry
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Samer AlMasri, MD
- Responsible party
- Sponsor-investigator, Mohammad Haroon Asif Choudry, University of Pittsburgh
- Investigators
- Haroon Choudry, MBBS, FACS, Principal investigator, UPMC Hillman Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07475286
- Sponsor's protocol ID
- HCC 25-124
- Status last verified
- Jun 2026
- First submitted
- 9 Mar 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No