Precision Chemotherapy Based on Organoid Drug Sensitivity for Colorectal Cancer

Nanfang Hospital, Southern Medical University

Status: Enrolling

Conditions: Colorectal Cancer

Treatments: Drug: FOLFOX , FOLFIRI or FOLFOXIRI regimens; Drug: FOLFOX or CapeOX regimens

Study type: Interventional

Funder types: Other

Identifiers

NCT05832398

NFEC-2022-471

Details and patient eligibility

About

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.

Full 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.

Enrollment: 186 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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186 participants in 2 patient groups

Organoid guided chemotherapy

Experimental group

Description:

Patients will receive sensitive chemotherapy in organoid drug test once every two weeks for 6 cycles as adjuvant chemotherapy

Treatment:

Drug: FOLFOX , FOLFIRI or FOLFOXIRI regimens

FOLFOX regimen

Active Comparator group

Description:

Patients will receive FOLFOX regimen once every two weeks for 6 cycles as adjuvant chemotherapy

Treatment:

Drug: FOLFOX or CapeOX regimens