Response Prediction of Hyperthermic Intraperitoneal Chemotherapy in Gastro- Intestinal Cancer

Last updated: May 27, 2025
Sponsor: Technische Universität Dresden
Overall Status: Active - Recruiting

Phase

N/A

Condition

Carcinoma

Abdominal Cancer

Digestive System Neoplasms

Treatment

Establishment of organoid cultures and in vitro sensitivity testing

Clinical Study ID

NCT05652348
VTG-12
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • (Suspected) synchronous or metachronous peritoneal metastasis of adenocarcinoma ofthe stomach / gastroesophageal junction (GEJ) or of the colon or rectum

  • intraoperative histological confirmation of synchronous or metachronous peritonealcarcinomatosis in gastric carcinoma (incl. GEJ) or colon carcinoma (incl. rectalcarcinoma)

  • Intraoperative peritoneal cancer index (PCI) ≤ 15 for gastric carcinoma and ≤ 20 forcolon carcinoma.

  • Possibility of surgical resection of peritoneal carcinomatosis (cytoreductivesurgery) in curative intention with achievement of a Completeness of CytoreductionScore (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 thestudy protocol

Exclusion

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 peritonectomyin 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, myocardialinfarction within the last 3 months before surgery, high-risk cardiac arrhythmias)

  • Secondary malignant disease that occurred <5 years ago (exception: early stage of alocalized 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 7Months after the end of treatment to become pregnant

Study Design

Total Participants: 48
Treatment Group(s): 1
Primary Treatment: Establishment of organoid cultures and in vitro sensitivity testing
Phase:
Study Start date:
December 08, 2022
Estimated Completion Date:
December 31, 2028

Connect with a study center

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

    Dresden,
    Germany

    Active - Recruiting

  • University Hospital Heidelberg

    Heidelberg,
    Germany

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.