Patient-tailored Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Colorectal Peritoneal Metastases (OrganoHIPEC)

Last updated: October 20, 2023
Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neoplasm Metastasis

Treatment

Patient-tailored hyperthermic intraperitoneal chemotherapy (HIPEC)

Clinical Study ID

NCT06057298
INT 0006/21
RF-2019-12370456
  • Ages 18-75
  • All Genders

Study Summary

The objective of this clinical trial is to demonstrate that cytoreductive surgery and patient-tailored hyperthermic intra-peritoneal chemotherapy (HIPEC) will increase efficacy in controlling peritoneal disease. Tridimensional cell cultures (organoids) derived from colorectal cancer peritoneal metastases are used to select the most active drugs in an in vitro HIPEC model on individual-patient level, based on the hypothesis that resistance to drug(s) routinely used for intraperitoneal delivery can explain peritoneal relapse after combined treatment, depending on the individual tumor biology;

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. diagnosis of peritoneal metastases from intestinal-type or mucinous colo-rectaladenocarcinoma, by histological/cytological confirmation.
  2. limited to moderate peritoneal involvement: peritoneal cancer index (PCI) ≤ 20;
  3. peritoneal disease potentially amenable to complete surgical cytoreduction;
  4. no evidence of hepatic, extra-regional nodal, or extra abdominal metastases
  5. World Health Organization (WHO) performance status ≤2;
  6. willingness to undergo preliminary laparoscopy, perioperative s-CT, and post-operativefollow-up;
  7. signature of informed consent.

Exclusion

Exclusion Criteria:

  1. active sepsis;
  2. impaired cardiac function (history of previous heart failure or 40% ejectionfraction);
  3. impaired renal function (serum creatinine >1.5 normal value or creatinine clearance < 60 ml/min);
  4. impaired liver function (aspartate aminotransferase, alanine aminotransferase,bilirubin > 1.5 normal value);
  5. impaired bone marrow function (leukocytes <4000/mm3, neutrophils <1500/mm3, platelets <80000/mm3);
  6. impaired lung function (diagnosis of severe chronic obstructive pulmonary disease or 50% forced expiratory volume at one second or 40% diffusion capacity of lung forcarbon monoxide adjusted for age);
  7. dehydropyrimidine dehydrogenase deficiency;
  8. pregnancy or lactation in progress;
  9. haemorrhagic diathesis or coagulopathy;
  10. any other condition or comorbidity that prevents safe administration of systemicchemotherapy (e.g. severe diarrhea, stomatitis or ulceration in the mouth orgastrointestinal tract);
  11. psychiatric or neurological conditions that preclude the procedures of the protocol;
  12. any contraindication to laparoscopy;
  13. known hypersensitivity to any of the chemotherapy agents used for HIPEC in the presentstudy and/or to any of their excipients;
  14. history of previous malignancies treated in the last three years, excluding cutaneousspinocellular carcinoma and/or basocellular carcinoma;
  15. previous cytoreductive surgery and HIPEC

Study Design

Total Participants: 24
Treatment Group(s): 1
Primary Treatment: Patient-tailored hyperthermic intraperitoneal chemotherapy (HIPEC)
Phase:
Study Start date:
June 15, 2021
Estimated Completion Date:
June 14, 2025

Study Description

This single-arm, single-center, open-label trial enrolls patients with limited and surgically resectable peritoneal metastases from colorectal cancer, no distant metastases, and no contraindication to major surgery. After signature of informed consent, patients undergo a preliminary laparoscopy to confirm diagnosis of peritoneal metastases, stage the disease, and obtain representative samples of peritoneal metastases. The investigators will use patient-derived organoids to select tailored hyperthermic intra-peritoneal chemotherapy (HIPEC) regimens in an in vitro model HIPEC. A set of candidate drugs suitable for intraperitoneal administration are tested on tumor-derived organoids under the same conditions as in the clinical practice (same drug combinations, concentration, exposure time, temperature). Different concentrations are tested to generate reproducible dose-response curves. Patients receive 3-6 month preoperative systemic chemotherapy with targeted agents, according to current guidelines. Those not experiencing disease progression during preoperative systemic chemotherapy will have cytoreductive surgery and HIPEC with drugs selected on the organoid-based preclinical model. Patients will undergo postoperative follow-up.

Connect with a study center

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milano, 20133
    Italy

    Active - Recruiting

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