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Optimization of Individualized Therapy for CRCs With Secondary RESISTance Towards Anti-EGFR Targeted Therapy Using an Avatar Model

NCT03263663 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2017-08-28

No results posted yet for this study

Summary

In this exploratory phase II trial, the possibility of a personalized treatment after resistance to cetuximab will be evaluated. Therefore, tumor material of all patients shall be obtained, transferred into avatars and treated the same way as in the patient until resistance arises. These resistant tumor cells are subsequently treated by different targeted treatment combinations in the mouse avatar model to find the most active drug or combination of drugs. This drug or combination of drugs may then be offered to the patient after cetuximab resistance has occurred. Multiple liquid biopsies shall be obtained in patients during first-line treatment with cetuximab as well as during second line experimental treatment to monitor mutations that may be associated with cetuximab resistance. Furthermore at the time of resistance a biopsy should be taken and analyzed to ensure that the mechanism of resistance seen in the avatar model matches with the mechanism of resistance in the individual patient.

Conditions

  • Colo-rectal Cancer
  • RAS Wild-type
  • UICC III
  • UICC II + RF
  • UICC IV Curative Intent

Interventions

DRUG

targeted substance according to the avatar model

individualized second line treatment

Sponsors & Collaborators

  • MGO Ruhr-University Bochum (RUB)

    collaborator UNKNOWN

  • PD Dr. med. Volker Heinemann

    lead OTHER

Principal Investigators

  • Sebastian Stintzing, Prof. Dr. · Senior Physician

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2021-01-01
Completion
2025-01-01

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03263663 on ClinicalTrials.gov