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Enrolling by Invitation

NCT Number: NCT07139951

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

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.

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Key information

Conditions

Clinical Stage I Gastric Cancer AJCC v8 Clinical Stage I Gastroesophageal Junction Adenocarcinoma AJCC v8 Clinical Stage II Gastric Cancer AJCC v8 Clinical Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8 Clinical Stage III Gastric Cancer AJCC v8 Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 Gastric Adenocarcinoma Gastroesophageal Junction Adenocarcinoma

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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)

Exclusion criteria

  • 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:
  • 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

Treatment and study plan

Biopsy Procedure

Procedure

Undergo laparoscopy with biopsy

Other names: Biopsy, BIOPSY_TYPE, Bx

Biospecimen Collection

Procedure

Undergo blood sample collection

Other names: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Cisplatin

Drug

Given IP

Other names: Abiplatin, Blastolem, Briplatin, CDDP, Cis-diammine-dichloroplatinum, Cis-diamminedichloridoplatinum, Cis-diamminedichloro Platinum (II), Cis-diamminedichloroplatinum, Cis-dichloroammine Platinum (II), Cis-platinous Diamine Dichloride, Cis-platinum, Cis-platinum II, Cis-platinum II Diamine Dichloride, Cismaplat, Cisplatina, Cisplatinum, Cisplatyl, Citoplatino, Citosin, Cysplatyna, DDP, Lederplatin, Metaplatin, Neoplatin, Peyrone's Chloride, Peyrone's Salt, Placis, Plastistil, Platamine, Platiblastin, Platiblastin-S, Platinex, Platinol, Platinol- AQ, Platinol-AQ, Platinol-AQ VHA Plus, Platinoxan, Platinum, Platinum Diamminodichloride, Platiran, Platistin, Platosin

Computed Tomography

Procedure

Undergo PET/CT

Other names: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography

Hyperthermic Intraperitoneal Chemotherapy

Drug

Given p-HIPEC

Other names: HIPEC

Laparoscopy

Procedure

Undergo laparoscopy with biopsy

Other names: LP

Lymphadenectomy

Procedure

Undergo D2 lymphadenectomy

Other names: excision of the lymph node, Lymph Node Dissection, Lymph Node Excision

Magnetic Resonance Imaging

Procedure

Undergo PET/MRI

Other names: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

paclitaxel

Drug

Given IP

Other names: Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat

Positron Emission Tomography

Procedure

Undergo PET/CT or PET/MRI

Other names: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT

Surgical Procedure

Procedure

Undergo gastrectomy and reconstruction

Other names: Operation, Surgery, Surgery Type, Surgery, NOS, Surgical, Surgical Intervention, Surgical Interventions, Surgical Procedures, Type of Surgery

Primary outcomes

  1. Peritoneal Recurrence-free Survival

    Time frame: Up to 18 months

    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.

Secondary outcomes

  1. Safety and Tolerability (Adverse Events)

    Time frame: Up to 45 days after study treatment

    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.

  2. Recurrence-free Survival

    Time frame: Up to 5 years

    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.

  3. Overall Survival

    Time frame: 3 years and 5 years

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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2031
First posted
Aug 24, 2025
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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