Response Prediction of Hyperthermic Intraperitoneal Chemotherapy in Gastro- Intestinal Cancer (Hi-STEP1)

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.

Study Overview

• Status: Recruiting
• Conditions: Gastric Cancer; Colon Cancer; Peritoneal Carcinomatosis
• Intervention / Treatment: Other: Establishment of organoid cultures and in vitro sensitivity testing

• Study Type: Observational
• Enrollment (Estimated): 48

Contacts and Locations

• Study Contact: Name: Daniel Stange, Prof. Dr.; Phone Number: +49 351 458 4098; Email: daniel.stange@ukdd.de

Study Locations

• Germany
  • Dresden, Germany
    • Recruiting
    • Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustv Carus Dresden
    • Contact: Daniel Stange, Prof. Dr.
  • Heidelberg, Germany
    • Not yet recruiting
    • University Hospital Heidelberg
    • Contact: Martin Schneider, Prof. Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Eligible patients are recruited consecutively during of the initial surgical treatment planning

Description

Inclusion Criteria:

• (Suspected) synchronous or metachronous peritoneal metastasis of adenocarcinoma of the stomach / gastroesophageal junction (GEJ) or of the colon or rectum
• intraoperative histological confirmation of synchronous or metachronous peritoneal carcinomatosis in gastric carcinoma (incl. GEJ) or colon carcinoma (incl. rectal carcinoma)
• Intraoperative peritoneal cancer index (PCI) ≤ 15 for gastric carcinoma and ≤ 20 for colon carcinoma.
• Possibility of surgical resection of peritoneal carcinomatosis (cytoreductive surgery) in curative intention with achievement of a Completeness of Cytoreduction Score (CCS) of 0-1
• No contraindication to surgery
• No contraindication against the performance of HIPEC
• Expected survival of 6 months at least
• ECOG ≤ 2
• Female and male patients ≥ 18 years of age
• Patient is able and willing to give written informed consent and comply with the study protocol

Exclusion Criteria:

• Presence of non-resectable distant metastases
• Patients with extensive metastasis (e.g., multiple bilobular liver metastases, hepatic and pulmonary metastases, multiple retroperitoneal lymph node metastases; oligometastasis is allowed)
• Patients with recurrence of peritoneal carcinomatosis (e.g., previous peritonectomy in the course of primary tumor resection)
• Patients after previous palliative chemotherapy or radiation of the tumor (exception: neoadjuvant and/or adjuvant therapies)
• Hypersensitivity/allergy to components of the planned intraperitoneal chemotherapy
• Patients not eligible for surgery/HIPEC (e.g., heart failure NYHA ≥III, myocardial infarction within the last 3 months before surgery, high-risk cardiac arrhythmias)
• Secondary malignant disease that occurred <5 years ago (exception: early stage of a localized tumor with in-sano resection, for example in situ carcinoma of the cervix, Adequately treated basal cell carcinoma of the skin)
• Patients who are housed in a closed facility
• Pregnant or breastfeeding patients, or patients who plan to become pregnant within 7 Months after the end of treatment to become pregnant

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the sensitivity of the in vitro response of the organoid model to chemotherapeutic agents	Organoid treatment by means of ascending doses of chemotherapy and under HIPEC conditions, i.e. with elevated temperature	1 year
Next generation sequencing of organoid cultures	Sequencing of DNA and RNA (Ribonucleic acid)	1 year

Collaborators and Investigators

• Sponsor: Technische Universität Dresden
• Collaborators: German Cancer Research Center
• Investigators: Principal Investigator: Daniel Stange, Prof. Dr., University Hospital Carl Gustav Carus Dresden

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2022
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: December 7, 2022
• First Submitted That Met QC Criteria: December 7, 2022
• First Posted (Actual): December 15, 2022

Study Record Updates

• Last Update Posted (Actual): May 29, 2025
• Last Update Submitted That Met QC Criteria: May 27, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Organoid
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Neoplasms, Glandular and Epithelial; Peritoneal Diseases; Abdominal Neoplasms; Carcinoma; Gastrointestinal Neoplasms; Intestinal Neoplasms; Peritoneal Neoplasms
• Other Study ID Numbers: VTG-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No