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Lab-Grown tumor models may predict who benefits from heated chemotherapy

NCT ID NCT05652348

Knowledge-focused Sponsor: Technische Universität Dresden Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This study tests whether tumor organoids grown from biopsies can predict how well patients with gastric or colon cancer and peritoneal carcinomatosis respond to hyperthermic intraperitoneal chemotherapy (HIPEC). Researchers collect tumor samples during standard surgery, grow them in the lab, and expose them to chemotherapy under heated conditions. They also analyze the organoids' genetics to find targets for potential targeted drugs. The goal is to develop a laboratory test that guides personalized treatment decisions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Patient-derived tumor organoid cultures and in vitro sensitivity testing
What this could lead to
If successful, this could help doctors predict which patients with peritoneal carcinomatosis will benefit from HIPEC and guide targeted therapy choices.
What could go wrong
This is an early laboratory-based study with a small number of participants. Organoid responses may not perfectly mirror real tumor behavior in the body, and the findings may not change clinical practice immediately.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 48 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2022

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Eligible patients are recruited consecutively during of the initial surgical treatment planning

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

colon carcinoma colonic neoplasm gastric cancer gastric neoplasm peritoneal carcinomatosis peritoneal neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colon cancer Gastric cancer Peritoneal carcinomatosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum

    RECRUITING

    Berlin, 13353, Germany

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

    RECRUITING

    Dresden, Germany

  • Universitätsklinikum Köln (AöR), Klinik und Poliklinik für Allgemein-, Viszeral-, Thorax- und Gefäßchirurgie

    RECRUITING

    Cologne, 50937, Germany

  • Universitätsklinikum Ulm, Klink für Innere Medizin I

    NOT_YET_RECRUITING

    Ulm, 89081, Germany

  • Universitätsklinikum Würzburg, Chirurgie I - Klink und Poliklinik für Allgemein-, Viszeral-, Transplantations-, Gefäß- und Kinderchirurgie

    RECRUITING

    Würzburg, 97080, Germany

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