Precision Chemotherapy Based on Organoid Drug Sensitivity for Colorectal Cancer

Not Applicable

Recruiting

• Conditions: Colorectal Cancer
• Interventions: Drug: FOLFOX , FOLFIRI or FOLFOXIRI regimens; Drug: FOLFOX or CapeOX regimens

• Registration Number: NCT05832398
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

The purpose of this study is to investigate whether chemotherapy guided by patient-derived tumor organoid drug test can improve the outcomes of stage IV colorectal cancer.

Detailed Description

Fluorouracil-based chemotherapy is the standard treatment for stage IV colorectal cancer patients. However, the effects of chemotherapy remains limited. Patient-derived tumor organoids are increasingly used as tools for drug test and predicting drug response in the clinic, and have been showed to faithfully predict clinical outcomes of patients with CRC. A prospective clinical trial is needed to validate whether the in vitro sensitivity to chemotherapy regimens in organoids drug test is associated with a longer PFS in stage IV colorectal cancer.

Study Timeline

• Study First Submitted: 2023-02-06
• Study First Submitted QC: 2023-04-26
• Study First Posted: 2023-04-27
• Study Start: 2023-05-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-27
• Last Update Posted: 2023-06-28
• Primary Completion: 2025-01-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 186

Inclusion Criteria

• Age between 18 and 70
• Histological confirmed colorectal cancer
• Stage IV
• American Society of Anesthesiologists (ASA) score I~III
• No contraindication for chemotherapy
• No evidence of other malignant tumor

Exclusion Criteria

• Refusing chemotherapy
• Pregnant or breast-feeding women
• Severe organ damage after chemotherapy, surgery or unable to continue to systemic chemotherapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Organoid guided chemotherapy	FOLFOX , FOLFIRI or FOLFOXIRI regimens	Patients will receive sensitive chemotherapy in organoid drug test once every two weeks for 6 cycles as adjuvant chemotherapy
FOLFOX regimen	FOLFOX or CapeOX regimens	Patients will receive FOLFOX regimen once every two weeks for 6 cycles as adjuvant chemotherapy

Primary Outcome Measures

Name	Time	Method
1. Progression-free survival	up to 1 years	the time from randomization to relapse or death, whichever occurred first

Secondary Outcome Measures

Name	Time	Method
Overall survival	up to 5 years	the time from randomization to death from any cause

Trial Locations

Locations (1)

Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China