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RecruitingNCT05652348Hi-STEP1Updated Aug 27, 2026

Response Prediction of Hyperthermic Intraperitoneal Chemotherapy in Gastro- Intestinal Cancer

An observational study in Gastric Cancer, Colon Cancer and Peritoneal Carcinomatosis, sponsored by Technische Universität Dresden. Recruiting at 5 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.

Sponsored by Technische Universität Dresden · Observational

From the registry’s dates

  • Started Dec 2022; still recruiting 3 years 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
48
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Gastric Cancer
  • Colon Cancer
  • Peritoneal Carcinomatosis

Keywords

  • Organoid
03

In context

Stomach Neoplasms

3,399 studies on the registry are indexed under Stomach Neoplasms; 992 are open to participants now.

This study's planned enrollment of 48 is below the median of 278 across 790 observational studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Technische Universität Dresden is the lead sponsor of 247 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • (Suspected) synchronous or metachronous peritoneal 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 to surgery
  • No contraindication against the performance of HIPEC
  • Expected survival of 6 months at least
  • ≤ 2
  • Female and male patients ≥ 18 years of age
  • Patient is able and willing to give written and comply with the study protocol

Exclusion criteria

Exclusion Criteria:

  • Presence of non-resectable distant
  • 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: and/or adjuvant therapies)
  • /allergy to components of the planned intraperitoneal chemotherapy
  • Patients not eligible for surgery/HIPEC (e.g., heart failure ≥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
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
48 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

  • OtherEstablishment of organoid cultures and in vitro sensitivity testing

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 year

  2. Next generation sequencing of organoid cultures

    Sequencing of DNA and RNA (Ribonucleic acid)

    Time frame: 1 year

07

Study locations

4 of 5 sites recruiting
  • Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum
    Berlin, 13353, Germany
    Recruiting
    • Beate Rau, Prof. Dr. · Contact
  • Universitätsklinikum Köln (AöR), Klinik und Poliklinik für Allgemein-, Viszeral-, Thorax- und Gefäßchirurgie
    Cologne, 50937, Germany
    Recruiting
    • Thomas Schmidt, Prof. Dr. Dr. · Contact
  • Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustv Carus Dresden
    Dresden, Germany
    Recruiting
    • Daniel Stange, Prof. Dr. · Contact
  • Universitätsklinikum Ulm, Klink für Innere Medizin I
    Ulm, 89081, Germany
    Not yet recruiting
    • Thomas Seufferlein, Prof. Dr. · Contact
  • Universitätsklinikum Würzburg, Chirurgie I - Klink und Poliklinik für Allgemein-, Viszeral-, Transplantations-, Gefäß- und Kinderchirurgie
    Würzburg, 97080, Germany
    Recruiting
    • Nicolas Schlegel, Prof. Dr. · Contact
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05652348
Collaborators
German Cancer Research Center
Responsible party
Sponsor
First posted
Dec 15, 2022
Start date
Dec 8, 2022
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Aug 27, 2026

Study contacts

Daniel Stange, Prof. Dr.
Contact
daniel.stange@ukdd.de
+49 351 458 4098
Daniel Stange, Prof. Dr.
principal investigator · University Hospital Carl Gustav Carus Dresden

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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