Response Prediction of Hyperthermic Intraperitoneal Chemotherapy in Gastro- Intestinal Cancer

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.

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Key information

Conditions

Gastric Cancer Abdominal Neoplasms Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Peritoneal Carcinomatosis Peritoneal Diseases Peritoneal Neoplasms Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustv Carus Dresden, Dresden, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Establishment of organoid cultures and in vitro sensitivity testing

Other

Generating patient-derived tumor organoid models as well as orthotopic mouse models from peritoneal carcinomatosis lesions and to investigate their response to different therapies.

Primary outcomes

Evaluation of the sensitivity of the in vitro response of the organoid model to chemotherapeutic agents

Time frame: 1 year

Organoid treatment by means of ascending doses of chemotherapy and under HIPEC conditions, i.e. with elevated temperature
Next generation sequencing of organoid cultures

Time frame: 1 year

Sequencing of DNA and RNA (Ribonucleic acid)

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel Stange, Prof. Dr.

CONTACT

[email protected]

+49 351 458 4098

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Collaborators

German Cancer Research Center

Registry information

Acronym: Hi-STEP1

Important dates

Study start: 2022
Primary completion: 2028
Study completion: 2028
First posted: Dec 15, 2022
Registry last updated: May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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