Clinical Trial

Response Prediction of Hyperthermic Intraperitoneal Chemotherapy in Gastro- Intestinal Cancer

Study acronym: Hi-STEP1
Recruiting
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Summary
Patients with gastric or colon cancer with peritoneal carcinomatosis will receive a biopsy of the tumor during their primary curative surgery. The operation is performed according to standard and includes resection of the primary tumor and any metastases and followed by HIPEC (Intraperitoneal hyperthermic chemoperfusion) according to the respective hospital standard. Organoid cultures from the biopsies are established in the research laboratory. Various chemotherapeutic agents are tested on these tumor organoids in the laboratory and the tumor organoids are analyzed in detail with regard to genetic alterations in order to find alterations that can be addressed, if necessary, by means of targeted drugs against peritoneal carcinomatosis.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2022-12-07; most recent amendment 2025-05-27.
Status change: Not Yet Recruiting → Recruiting 2023-01-11
Trial Details
NCT Number NCT05652348
Lead Sponsor Technische Universität Dresden
Collaborators: German Cancer Research Center
Conditions Gastric Cancer, Colon Cancer, Peritoneal Carcinomatosis
Enrollment 48 participants
Start Date 2022-12-08
Primary Completion 2028-12-31 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-05-29