NCT05652348Recruiting
Response Prediction of Hyperthermic Intraperitoneal Chemotherapy in Gastro- Intestinal Cancer
Source: ClinicalTrials.gov · Last updated 27 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 48 (estimated)
- First submitted
- 7 Dec 2022
- Start date
- 8 Dec 2022
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Technische Universität Dresden
- NCT number
- NCT05652348
What you commit to
- Study type: Observational
- Planned participants: 48
- From 8 Dec 2022 to the primary completion date, 31 Dec 2028
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- 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)
Other illness
- Hypersensitivity/allergy to components of the planned intraperitoneal chemotherapy
Age
- 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)
Other
- 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 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
Who the study is looking for
- (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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Charite Universitatsmedizin Berlin Campus Virchow Klinikum Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Universitätsklinikum Köln (AöR), Klinik und Poliklinik für Allgemein-, Viszeral-, Thorax- und Gefäßchirurgie Coordinator of this site? Confirm its status | Cologne | Germany | Recruiting |
| Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustv Carus Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Recruiting |
| Universitätsklinikum Ulm, Klink für Innere Medizin I Coordinator of this site? Confirm its status | Ulm | Germany | Not yet recruiting |
| Universitätsklinikum Würzburg, Chirurgie I - Klink und Poliklinik für Allgemein-, Viszeral-, Transplantations-, Gefäß- und Kinderchirurgie Coordinator of this site? Confirm its status | Würzburg | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.