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Search / Trial NCT06295094

The Efficacy of PIPAC and Minimally Invasive Radical Resection in High-risk Gastric Cancer Patients.

Launched by ODENSE UNIVERSITY HOSPITAL · Mar 5, 2024

Trial Information

Current as of July 22, 2025

Not yet recruiting

Keywords

Pipac Gastric Cancer Minimally Invasive Gastrectomy

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with high-risk gastric cancer. The researchers want to find out if a procedure called pressurized intraperitoneal chemotherapy (PIPAC) can help improve survival without cancer returning in the abdominal area after patients undergo a specific type of surgery called minimally invasive D2 gastrectomy. In this trial, some participants will receive PIPAC treatment right after their surgery and again a few weeks later, while others will receive standard treatment.

To be eligible for this trial, participants should be between the ages of 18 and 80 and diagnosed with certain types of gastric or gastroesophageal junction cancers that are at a specific stage. They also need to be in good overall health, meaning they can carry out daily activities without significant problems. If you or someone you know is interested in joining this trial, it’s important to discuss it with a healthcare provider to see if it’s a good fit. Participants can expect to receive close monitoring and support throughout the study, helping researchers learn more about this new treatment option.

Gender

ALL

Eligibility criteria

  • Inclusion criteria
  • Gastric or Gastroesophageal junction Siewert type III adenocarcinomas
  • Clinical T3-4a-stages
  • 1. Any differentiation grade
  • 2. Any histological subtype
  • Clinical T2-stage
  • a. If poorly differentiated or of the poorly cohesive histological subtype, with or without the presence of signet-ring cells
  • Any clinical T-stage with positivity for malignant cells on abdominal lavage cytology, which is converted to cytology negative in response to neoadjuvant chemotherapy.
  • Any clinical nodal-stage
  • clinical M0-stage (positive abdominal wash cytology, which is converted to cytology negative in response to neoadjuvant therapy, is permitted)
  • Performance status Eastern Cooperative Oncology Group (ECOG) 0-1
  • Age 18 - 80 years
  • Undergoing robotic or laparoscopic D2 gastrectomy
  • Able and willing to provide written informed consent and to comply with the clinical study protocol
  • Fertile women must have a negative pregnancy test at the time of inclusion and must use adequate contraception.
  • Exclusion criteria
  • Previous allergic reaction to cisplatin, doxorubicin or other platinum-containing compounds.
  • Renal impairment, defined as glomerular filtration rate (GFR) \< 40 ml/min (Cockcroft-Gault Equation).
  • Myocardial insufficiency, defined as New York Heart Association (NYHA) class 3-4.
  • An impaired liver function, defined as bilirubin ≥ 1.5 x upper normal limit (UNL).
  • An inadequate haematological function, defined as absolute neutrophil count (ANC) \<1.5 x 109/l and platelets \<100 x 109/l.
  • Any other condition or therapy which, in the investigator's opinion, may pose a risk to the patient or interfere with the study objectives.

About Odense University Hospital

Odense University Hospital is a leading academic medical center located in Denmark, dedicated to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical studies, the hospital is committed to enhancing patient outcomes and fostering collaboration among multidisciplinary teams. With a focus on translating scientific discoveries into practical applications, Odense University Hospital leverages its state-of-the-art facilities and expertise to conduct rigorous trials across various medical fields, ensuring adherence to the highest ethical and regulatory standards. Through these efforts, the hospital aims to contribute significantly to the global body of medical knowledge and improve the quality of care for patients both locally and internationally.

Locations

Duarte, California, United States

Odense C, , Denmark

Stockholm, , Sweden

Lille, , France

Berlin, , Germany

Patients applied

0 patients applied

Trial Officials

Michael Bau Mortensen, DMSci, PhD

Study Director

University of Southern Denmark (sdu.dk)

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported