NCT04906733

Cetuximab Sensitivity Correlation Between Patient-Derived Organoids and Clinical Response in Colon Cancer Patients.

Patient-derived Organoids of RAS/RAF Wild-type Metastatic Right Colon Cancer to Test the Sensitivity and Clinical Consistency of Combined Treatment of Cetuximab.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: D1 Medical Technology (Shanghai) Co., Ltd, China · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Eighty patients with RAS/RAF wild-type metastatic right colon cancer will be enrolled and undergo a fresh biopsy of tumor lesion before the standard treatment of chemotherapy. The investigators will establish organoids from the pre-treatment biopsies. Organoids will be exposed to the chemotherapy drugs or chemotherapy drugs combined with cetuximab used for each patient. The sensitivity of chemotherapy drugs or combined cetuximab will be tested in the organoids model. Chemotherapy strategies including 5-fluorouracil only, irinotecan only, oxaliplatin only, FOLFOX, and FOLFIRI. The purpose of this study is to evaluate the consistency and accuracy of a Patient-Derived Organoid (PDO) model of colon cancer to predict the clinical efficacy of combined treatment of cetuximab, which to formulate the best therapy regimen for each given patient.

Detailed description

Investigators hypothesize that the cetuximab sensitivity test results on patient-derived organoids can be used to predict the treatment selection of patients with RAS/RAF wild-type metastatic right colon cancer. Objectives 1. To assess the effective rate of cetuximab target therapy on RAS/RAF wild-type right colon cancer 2. To assess the consistency of organoid chemotherapy sensitivity and clinical chemotherapy efficacy 3. To assess the consistency of organoid cetuximab sensitivity and clinical cetuximab efficacy The following points will be addressed: 1. The biopsy tissue of RAS/RAF wild-type metastatic right colon cancer will be collected and subject to ex vivo 3-D culture to establish patient-derived tumor organoids, which will be used for the drug sensitivity test. 2. Enrolled patients will treat with chemotherapy or chemotherapy combined target therapy. The medication regime and treatment cycle will be decided based on the clinical guideline and evidence-based medicine. 3. The patient-derived organoid-based drug sensitivity test will compare with clinical treatment data of chemotherapy or chemotherapy combined target therapy, followed by correlation analysis.

Conditions

• Colon Cancer
• Organoids
• Metastatic Cancer

Interventions

Type	Name	Description
PROCEDURE	Tumor biopsy	Patients with RAS/RAF wild-type metastatic right colon cancer will receive biopsy before the standard treatment of chemotherapy or target therapy.

Timeline

• Start date: 2021-04-15
• Primary completion: 2023-06-01
• Completion: 2023-12-01
• First posted: 2021-05-28
• Last updated: 2021-08-13

Locations

1 site across 1 country: China