NCT05652348: Hi-STEP1

Response Prediction of Hyperthermic Intraperitoneal Chemotherapy in Gastro- Intestinal Cancer

Recruiting now Last updated 29 May 2025

What this trial tests

trial testing Establishment of organoid cultures and in vitro sensitivity testing in Gastric Cancer in 48 participants. Currently enrolling.

Timeline

8 December 2022

Primary endpoint
31 December 2028

31 December 2028

Quick facts

Lead sponsor	Technische Universität Dresden
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	48
Start date	8 December 2022
Primary completion	31 December 2028
Estimated completion	31 December 2028
Sites	2 locations across Germany

Drugs / interventions tested

• Establishment of organoid cultures and in vitro sensitivity testing

Conditions studied

• Gastric Cancer — all drugs for Gastric Cancer →
• Colon Cancer — all drugs for Colon Cancer →
• Peritoneal Carcinomatosis — all drugs for Peritoneal Carcinomatosis →

Sponsor

Technische Universität Dresden — full company profile →

Who can join

18 and older, any sex, with Gastric Cancer or Colon Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Organoids: The current status and biomedical applications.
   Yang S, Hu H, Kung H, Zou R, et al · · 2023 · cited 162× · PMID 37215622 · DOI 10.1002/mco2.274
2. Organoids: development and applications in disease models, drug discovery, precision medicine, and regenerative medicine.
   Yao Q, Cheng S, Pan Q, Yu J, et al · · 2024 · cited 40× · PMID 39309690 · DOI 10.1002/mco2.735
3. Current applications of intestinal organoids: a review.
   Xiang T, Wang J, Li H. · · 2024 · cited 27× · PMID 38816841 · DOI 10.1186/s13287-024-03768-3
4. Tumour organoids and assembloids: Patient-derived cancer avatars for immunotherapy.
   Mei J, Liu X, Tian HX, Chen Y, et al · · 2024 · cited 25× · PMID 38664597 · DOI 10.1002/ctm2.1656
5. The application of organoids in investigating immune evasion in the microenvironment of gastric cancer and screening novel drug candidates.
   Kan L, Yu Y, Wang Y, Shi L, et al · · 2025 · cited 6× · PMID 40287758 · DOI 10.1186/s12943-025-02328-4
6. The application of organoids in treatment decision-making for digestive system cancers: progress and challenges.
   Wang Y, Zhang L, Wang LZ, Cao Y, et al · · 2025 · cited 4× · PMID 40855314 · DOI 10.1186/s12943-025-02429-0
7. Human patient derived organoids: an emerging precision medicine model for gastrointestinal cancer research.
   Yan S, He Y, Zhu Y, Ye W, et al · · 2024 · cited 4× · PMID 38638528 · DOI 10.3389/fcell.2024.1384450
8. Modeling Liver Development and Disease in a Dish.
   Iqbal W, Wang Y, Sun P, Zhou X. · · 2023 · cited 4× · PMID 37958904 · DOI 10.3390/ijms242115921