Hyperthermic Intraperitoneal Chemotherapy With Cisplatin and Paclitaxel for the Treatment of Patients With Gastric and Gastroesophageal Junction Adenocarcinoma at High Risk of Peritoneal Recurrence

NCT07139951 | Enrolling By Invitation Phase 2 FDA Drug

• 3 other identifiers: MC240402NCI-2025-0584524-013133
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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 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.

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

Outcome Measures

Primary Outcomes (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.

  Up to 18 months

Secondary Outcomes (3)

• Safety and Tolerability (Adverse Events)

  Up to 45 days after study treatment

• Recurrence-free Survival

  Up to 5 years

• Overall Survival

  3 years and 5 years

Study Arms (1)

Treatment (p-HIPEC, cisplatin, paclitaxel)

EXPERIMENTAL

Patients 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.

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

Interventions

Biopsy Procedure PROCEDURE

Undergo laparoscopy with biopsy

Also known as: Biopsy, BIOPSY_TYPE, Bx

Treatment (p-HIPEC, cisplatin, paclitaxel)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Treatment (p-HIPEC, cisplatin, paclitaxel)

Cisplatin DRUG

Given IP

Also known as: 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

Treatment (p-HIPEC, cisplatin, paclitaxel)

Computed Tomography PROCEDURE

Undergo PET/CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography

Treatment (p-HIPEC, cisplatin, paclitaxel)

Hyperthermic Intraperitoneal Chemotherapy DRUG

Given p-HIPEC

Also known as: HIPEC

Treatment (p-HIPEC, cisplatin, paclitaxel)

Laparoscopy PROCEDURE

Undergo laparoscopy with biopsy

Also known as: LP

Treatment (p-HIPEC, cisplatin, paclitaxel)

Lymphadenectomy PROCEDURE

Undergo D2 lymphadenectomy

Also known as: excision of the lymph node, Lymph Node Dissection, Lymph Node Excision

Treatment (p-HIPEC, cisplatin, paclitaxel)

Magnetic Resonance Imaging PROCEDURE

Undergo PET/MRI

Also known as: 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

Treatment (p-HIPEC, cisplatin, paclitaxel)

Paclitaxel DRUG

Given IP

Also known as: Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat

Treatment (p-HIPEC, cisplatin, paclitaxel)

Positron Emission Tomography PROCEDURE

Undergo PET/CT or PET/MRI

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT

Treatment (p-HIPEC, cisplatin, paclitaxel)

Surgical Procedure PROCEDURE

Undergo gastrectomy and reconstruction

Also known as: Operation, Surgery, Surgery Type, Surgery, NOS, Surgical, Surgical Intervention, Surgical Interventions, Surgical Procedures, Type of Surgery

Treatment (p-HIPEC, cisplatin, paclitaxel)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Biopsy; Specimen Handling; Cisplatin; 1,2-diaminocyclohexaneplatinum II citrate; Platinum; Hyperthermic Intraperitoneal Chemotherapy; Laparoscopy; Lymph Node Excision; Magnetic Resonance Spectroscopy; Paclitaxel; Taxes; Surgical Procedures, Operative

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Surgical; Investigative Techniques; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Metals, Heavy; Elements; Transition Elements; Metals; Chemotherapy, Adjuvant; Combined Modality Therapy; Therapeutics; Drug Therapy; Hyperthermia, Induced; Endoscopy; Minimally Invasive Surgical Procedures; Spectrum Analysis; Chemistry Techniques, Analytical; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Economics; Health Care Economics and Organizations

Study Officials

• Travis E. Grotz, MD, MS

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: August 24, 2025
• Study Start: December 3, 2025
• Primary Completion (Estimated): May 3, 2027
• Study Completion (Estimated): November 3, 2031
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

US (1)