Response Prediction of Hyperthermic Intraperitoneal Chemotherapy in Gastro- Intestinal Cancer

NCT ID: NCT05652348

Last Updated: 2025-05-29

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 48 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-12-08
• Study Completion Date: 2028-12-31

Brief 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.

Conditions

Gastric Cancer; Colon Cancer; Peritoneal Carcinomatosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Establishment 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• (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

Exclusion Criteria

• 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)
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German Cancer Research Center

OTHER

Sponsor Role: collaborator

Technische Universität Dresden

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Stange, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Carl Gustav Carus Dresden

Locations

Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustv Carus Dresden

Dresden, , Germany

Site Status: RECRUITING

University Hospital Heidelberg

Heidelberg, , Germany

Site Status: NOT_YET_RECRUITING

Countries

Germany

Central Contacts

Daniel Stange, Prof. Dr.

Role: CONTACT

daniel.stange@ukdd.de

+49 351 458 4098

Facility Contacts

Daniel Stange, Prof. Dr.

Role: primary

Martin Schneider, Prof. Dr.

Role: primary

Other Identifiers

VTG-12

Identifier Type: -

Identifier Source: org_study_id