NCT03263663: 2016-003295-46

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

Status unknown Last updated 28 August 2017

What this trial tests

trial testing targeted substance according to the avatar model in Colo-rectal Cancer in 1,000 participants. Status unknown.

Timeline

1 January 2017

Primary endpoint
1 January 2021

1 January 2025

Quick facts

Lead sponsor	PD Dr. med. Volker Heinemann
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	1,000
Start date	1 January 2017
Primary completion	1 January 2021
Estimated completion	1 January 2025
Sites	1 location across Germany

Drugs / interventions tested

• targeted substance according to the avatar model — full drug profile →

Conditions studied

• Colo-rectal Cancer — all drugs for Colo-rectal Cancer →
• RAS Wild-type — all drugs for RAS Wild-type →
• UICC III — all drugs for UICC III →
• UICC II + RF — all drugs for UICC II + RF →

Sponsor

PD Dr. med. Volker Heinemann

Who can join

18 and older, any sex, with Colo-rectal Cancer or RAS Wild-type. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Current and Future Horizons of Patient-Derived Xenograft Models in Colorectal Cancer Translational Research.
   Inoue A, Deem AK, Kopetz S, Heffernan TP, et al · · 2019 · cited 31× · PMID 31500168 · DOI 10.3390/cancers11091321
2. Precision oncology using ex vivo technology: a step towards individualised cancer care?
   Williams ST, Wells G, Conroy S, Gagg H, et al · · 2022 · cited 14× · PMID 36184897 · DOI 10.1017/erm.2022.32
3. An overview of mechanisms, biomarkers, and treatment strategies for acquired anti-EGFR resistance in RAS wild-type colorectal cancer.
   Ding C, Yao R, Wang Y, Liu H, et al · · 2025 · PMID 41089844 · DOI 10.3389/fphar.2025.1656372