Gastric CancerHi-STEP1NCT05652348
Response Prediction of Hyperthermic Intraperitoneal Chemotherapy in Gastro- Intestinal Cancer
An observational study of Gastric Cancer and Colon Cancer, run by Technische Universität Dresden at 5 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Colon Cancer, Peritoneal Carcinomatosis
- What is being tested?
- Establishment of organoid cultures and in vitro sensitivity testing
- How many people
- 48 participants
- Where
- 5 sitesGermany
- Study dates
- 8 Dec 2022to 31 Dec 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible patients are recruited consecutively during of the initial surgical treatment planning
Who may be able to join
- (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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Germany5 sites, 5 recruiting
- Recruiting
Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum
Berlin, 13353
Beate Rau, Prof. Dr.
- Recruiting
Universitätsklinikum Köln (AöR), Klinik und Poliklinik für Allgemein-, Viszeral-, Thorax- und Gefäßchirurgie
Cologne, 50937
Thomas Schmidt, Prof. Dr. Dr.
- Recruiting
Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustv Carus Dresden
Dresden
Daniel Stange, Prof. Dr.
- Not yet recruiting
Universitätsklinikum Ulm, Klink für Innere Medizin I
Ulm, 89081
Thomas Seufferlein, Prof. Dr.
- Recruiting
Universitätsklinikum Würzburg, Chirurgie I - Klink und Poliklinik für Allgemein-, Viszeral-, Transplantations-, Gefäß- und Kinderchirurgie
Würzburg, 97080
Nicolas Schlegel, Prof. Dr.
About this study
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.
- Conditions
- Gastric Cancer, Colon Cancer, Peritoneal Carcinomatosis
- Being tested
- Establishment of organoid cultures and in vitro sensitivity testing
- Keywords
- Organoid
- Medical subject headings
- Stomach Neoplasms, Colonic Neoplasms, Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Establishment of organoid cultures and in vitro sensitivity testingOther
Generating patient-derived tumor organoid models as well as orthotopic mouse models from peritoneal carcinomatosis lesions and to investigate their response to different therapies.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Next generation sequencing of organoid cultures
Sequencing of DNA and RNA (Ribonucleic acid)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start8 Dec 2022
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- German Cancer Research Center
- Responsible party
- Sponsor
- Investigators
- Daniel Stange, Prof. Dr., Principal investigator, University Hospital Carl Gustav Carus Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05652348
- Sponsor's protocol ID
- VTG-12
- Acronym
- Hi-STEP1
- Status last verified
- Aug 2026
- First submitted
- 7 Dec 2022
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No