Actively Recruiting
Response Prediction of Hyperthermic Intraperitoneal Chemotherapy in Gastro- Intestinal Cancer
Led by Technische Universität Dresden · Updated on 2025-05-29
48
Participants Needed
2
Research Sites
316 weeks
Total Duration
On this page
Sponsors
T
Technische Universität Dresden
Lead Sponsor
G
German Cancer Research Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Response Prediction of Hyperthermic Intraperitoneal Chemotherapy in Gastro- Intestinal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Suspected synchronous or metachronous peritoneal metastasis of adenocarcinoma of the stomach, gastroesophageal junction, colon, or rectum
- Intraoperative histological confirmation of peritoneal carcinomatosis in gastric or colon carcinoma
- Peritoneal cancer index (PCI) 15 for gastric carcinoma and 20 for colon carcinoma
- Possibility of surgical resection of peritoneal carcinomatosis with Completeness of Cytoreduction Score (CCS) 0-1
- No contraindication to surgery
- No contraindication to HIPEC treatment
- Expected survival of at least 6 months
- ECOG performance status 2
- Female and male patients aged 18 years or older
- Ability and willingness to provide written informed consent and comply with study protocol
You will not qualify if you...
- Presence of non-resectable distant metastases
- Extensive metastasis such as multiple bilobular liver metastases, hepatic and pulmonary metastases, multiple retroperitoneal lymph node metastases (oligometastasis allowed)
- Recurrence of peritoneal carcinomatosis (e.g., prior peritonectomy during tumor resection)
- Previous palliative chemotherapy or radiation therapy (except neoadjuvant or adjuvant therapies)
- Known allergy or hypersensitivity to components of planned intraperitoneal chemotherapy
- Not eligible for surgery or HIPEC due to conditions like heart failure NYHA III, recent myocardial infarction within 3 months, or high-risk cardiac arrhythmias
- Secondary malignant disease within the past 5 years except certain early stage localized tumors adequately treated
- Patients housed in a closed facility
- Pregnant, breastfeeding, or planning pregnancy within 7 months after treatment
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustv Carus Dresden
Dresden, Germany
Actively Recruiting
2
University Hospital Heidelberg
Heidelberg, Germany
Not Yet Recruiting
Research Team
D
Daniel Stange, Prof. Dr.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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