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Clinical Stage I Gastric Cancer AJCC v8Phase 2NCT07139951

Hyperthermic Intraperitoneal Chemotherapy With Cisplatin and Paclitaxel for Gastric Cancer at High Risk of Peritoneal Recurrence

A Phase 2 study testing Biopsy Procedure, Biospecimen Collection and Cisplatin in people with Clinical Stage I Gastric Cancer AJCC v8 and Clinical Stage I Gastroesophageal Junction Adenocarcinoma AJCC v8, run by Mayo Clinic at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

This phase II trial tests how well concentrating heated (hyperthermic) chemotherapy in the area that contains the abdominal organs (intraperitoneal [IP]) at the time of surgery works in treating patients with gastric or gastroesophageal junction adenocarcinoma at high risk of the cancer coming back to the abdominal… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Biopsy Procedure, Biospecimen Collection and Cisplatin
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited States
Study dates
3 Dec 2025to 3 Nov 2031
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 and ≤ 80 years
  • Histological confirmation of adenocarcinoma of the stomach or gastroesophageal junction (GEJ) (Siewert type II or III)
  • Tumor index (TI) ≥ 90 (T stage multiplied by the largest tumor diameter in mm on endoscopic ultrasound [EUS]). Patients with linitus plastica automatically have TI ≥ 90
  • Hemoglobin ≥ 8.0 g/dL
  • Absolute neutrophil count (ANC) ≥ 1000/mm^3
  • Platelet count ≥ 75,000/mm^3
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  • Calculated creatinine clearance ≥ 60 ml/min using the Cockcroft-Gault formula
  • No radiographic or histological evidence of distant metastasis
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
  • Willingness to provide mandatory blood specimens for correlative research
  • Willingness to provide mandatory tissue specimens for correlative research
  • Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)

Who cannot join

  • Any of the following because this study involves an agent that has known genotoxic, mutagenic, and teratogenic effects:
  • Pregnant persons
  • Nursing persons
  • Persons of childbearing potential and persons able to father a child who are unwilling to employ adequate contraception
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
  • Uncontrolled intercurrent illness including, but not limited to:
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  • Ongoing or active infection
  • Symptomatic congestive heart failure
  • Unstable angina pectoris
  • Renal insufficiency (estimated glomerular filtration rate [eGFR] < 60)
  • Or psychiatric illness/social situations that would limit compliance with study requirements
  • Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
  • Active second malignancy currently receiving systemic treatment ≤ 6 months prior to pre-registration
  • History of myocardial infarction ≤ 6 months prior to pre-registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias

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

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Prophylactic Hyperthermic IntraperitOneal Chemotherapy (p-HIPEC) for pRevention of perItONeal Recurrence in Gastric Cancer: MC240402 (HORIZON) Trial

This phase II trial tests how well concentrating heated (hyperthermic) chemotherapy in the area that contains the abdominal organs (intraperitoneal [IP]) at the time of surgery works in treating patients with gastric or gastroesophageal junction adenocarcinoma at high risk of the cancer coming back to the abdominal cavity (peritoneal) after a period of improvement (recurrence). Recurrence in the peritoneum often occurs within the first 18 months after surgery. This is thought to be due to tumor cells that may scatter and spread during surgery. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Paclitaxel alone and in combination with other chemotherapy agents have been shown to be effective treatments for gastric tumors. However, systemic delivery of these drugs has not been shown to be effective in treating peritoneal metastasis. Hyperthermic intraperitoneal chemotherapy (HIPEC) is a procedure that involves the infusion of a heated chemotherapy solution, such as cisplatin and paclitaxel, that circulates into the abdominal cavity. Giving HIPEC with cisplatin and paclitaxel at the time of surgery may reduce peritoneal recurrence in patients with gastric or gastroesophageal junction adenocarcinoma at high risk.

Being tested
Biopsy Procedure, Biospecimen Collection, Cisplatin, Computed Tomography, Hyperthermic Intraperitoneal Chemotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biopsy ProcedureProcedure or surgery

    Also called Biopsy, BIOPSY_TYPE, Bx

    Undergo laparoscopy with biopsy

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

  • CisplatinDrug

    Also called Abiplatin, Blastolem, Briplatin, CDDP

    Given IP

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo PET/CT

  • Hyperthermic Intraperitoneal ChemotherapyDrug

    Also called HIPEC

    Given p-HIPEC

  • LaparoscopyProcedure or surgery

    Also called LP

    Undergo laparoscopy with biopsy

  • LymphadenectomyProcedure or surgery

    Also called excision of the lymph node, Lymph Node Dissection, Lymph Node Excision

    Undergo D2 lymphadenectomy

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo PET/MRI

  • PaclitaxelDrug

    Also called Anzatax, Asotax, Bristaxol, Praxel

    Given IP

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET/CT or PET/MRI

  • Surgical ProcedureProcedure or surgery

    Also called Operation, Surgery, Surgery Type, Surgery, NOS

    Undergo gastrectomy and reconstruction

Study groups in NCT07139951
Study groupRoleWhat they receive
Treatment (p-HIPEC, cisplatin, paclitaxel)ExperimentalPatients undergo gastrectomy with reconstruction per surgeon discretion and D2 lymphadenectomy and receive p-HIPEC with cisplatin and paclitaxel intraperitoneal (IP) over 90 minutes on study. Patients also undergo blood sample collection and PET/CT or PET/MRI throughout the study, as well as laparoscopy with biopsy during screening.
Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Drug: Cisplatin; Procedure: Computed Tomography; Drug: Hyperthermic Intraperitoneal Chemotherapy; Procedure: Laparoscopy; Procedure: Lymphadenectomy; Procedure: Magnetic Resonance Imaging; Drug: Paclitaxel; Procedure: Positron Emission Tomography; Procedure: Surgical Procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Peritoneal Recurrence-free Survival

    Patients will be followed in active surveillance with biomarkers (CEA and CA 19-9) and cross-sectional imaging of the chest, abdomen and pelvis. Only non-lymphatic, non-peranastomotic, and non-visceral intra-abdominal metastasis will be considered peritoneal metastasis. Ovarian metastasis will be considered peritoneal metastasis for this trial.

    Measured: Up to 18 months

Secondary outcomes (3)

  1. Safety and Tolerability (Adverse Events)

    Safety and tolerability will be determined by incidence of adverse events (AEs), specifically the incidence of grade 3 neutropenia and thrombocytopenia. AEs will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The incidence of acute kidney injury will be defined by the glomerular filtration rate (GFR) criteria of the Risk, Injury, Failure, Loss of kidney function and End-stage kidney disease (RIFLE) classification.

    Measured: Up to 45 days after study treatment

  2. Recurrence-free Survival

    Recurrence-free survival (RFS) is defined as the time from study entry to the first of either disease progression or death due to any cause. Any radiographic, endoscopic or biopsy proven recurrence of cancer will count as disease recurrence.

    Measured: Up to 5 years

  3. Overall Survival

    Overall survival (OS) is defined as the time from date of study entry to date of death or last follow up.

    Measured: 3 years and 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2025
  2. Study start3 Dec 2025
  3. Primary completion3 May 2027 (estimated)
  4. Study completion3 Nov 2031 (estimated)

Resources

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
16 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07139951
Sponsor's protocol ID
MC240402
Other IDs
24-013133, HORIZON, p-HIPEC
Status last verified
Jun 2026
First submitted
18 Aug 2025
Last updated
1 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biopsy Procedure, Biospecimen Collection and Cisplatin in people with Clinical Stage I Gastric Cancer AJCC v8 and Clinical Stage I Gastroesophageal Junction Adenocarcinoma AJCC v8, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peritoneal Recurrence-free Survival (time frame: Up to 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07139951.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.

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