NCT07139951

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

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

• Status: Enrolling By Invitation
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	Biopsy Procedure	Undergo laparoscopy with biopsy
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
DRUG	Cisplatin	Given IP
PROCEDURE	Computed Tomography	Undergo PET/CT
DRUG	Hyperthermic Intraperitoneal Chemotherapy	Given p-HIPEC
PROCEDURE	Laparoscopy	Undergo laparoscopy with biopsy
PROCEDURE	Lymphadenectomy	Undergo D2 lymphadenectomy
PROCEDURE	Magnetic Resonance Imaging	Undergo PET/MRI
DRUG	Paclitaxel	Given IP
PROCEDURE	Positron Emission Tomography	Undergo PET/CT or PET/MRI
PROCEDURE	Surgical Procedure	Undergo gastrectomy and reconstruction

Timeline

• Start date: 2025-12-03
• Primary completion: 2027-05-03
• Completion: 2031-11-03
• First posted: 2025-08-24
• Last updated: 2025-12-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study