Combined Chemotherapy for Gastric and Gastroesophageal Peritoneal Carcinomatosis

This study is looking into a new way to treat stomach (gastric) and/or food pipe (gastroesophageal) cancers that have spread to the lining of the abdomen (peritoneal carcinomatosis). It combines standard chemotherapy given through your veins with a procedure called laparoscopic hyperthermic intraperitoneal chemotherapy (HIPEC). During HIPEC, the drugs cisplatin and mitomycin C are warmed and washed directly inside your abdomen. The goal is to see if this combination can help people live longer without their cancer getting worse. You might be able to join if you are 18 or older and have been diagnosed with this type of cancer. The study plans to enroll 22 participants. We don't know the current enrollment status.

Study design
This study is an interventional study, meaning participants will receive a specific treatment. It plans to include 22 participants.
What's involved
You would receive standard chemotherapy every two weeks, and laparoscopic HIPEC procedures every six weeks, for a maximum of three HIPEC procedures.
Compensation
Not stated in the trial record.
Follow-up
The study will measure how long participants live without their cancer progressing, at one year.

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NCT07475286

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Mohammad Haroon Asif Choudry
~22 participants
Updated 2026-07-02 on ClinicalTrials.gov
What's tested:CisplatinMitomycin C

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
1-year Progression-free Survival (PFS)
Measured over At 1 year
Synchronous Gastric Peritoneal Carcinomatosis
Gastroesophageal Peritoneal Carcinomatosis
1 sites across 1 states
Pennsylvania1
  • Haroon Choudry, MBBS, FACS · PRINCIPAL_INVESTIGATOR · UPMC Hillman Cancer Center

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Eligibility criteria

Inclusion

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\*
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:
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

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).
  • 1-year Progression-free Survival (PFS)At 1 year

    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.