Precision Chemotherapy Based on Organoid Drug Sensitivity for Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

Precision Chemotherapy Based on Organoid for Colorectal CancerPatient-Derived Tumor Organoid Drug Sensitivity for Colorectal Cancer: A Prospective, Multicentre，Randomized, Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05832398
• Other study ID #: NFEC-2022-471
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: June 2023
• Source: Nanfang Hospital, Southern Medical University
• Contact: Jun Yan, M.D., Ph.D
• Phone: 086-13825066546
• Email: yanjunfudan[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 186
• Est. completion date: December 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• FOLFOX , FOLFIRI or FOLFOXIRI regimens
FOLFOX (oxaliplatin 85 mg/m2, and folinic acid 400 mg/m2 followed by 5-fluorouracil 400mg/m2 infusion, and 2400mg/m2 as a 46-hour continuous infusion on day 1) for 6 cycle FOLFIRI (irinotecan 150 mg/m2, and folinic acid 400 mg/m2 followed by 5-fluorouracil 400mg/m2 infusion, and 2400mg/m2 as a 46-hour continuous infusion on day 1) for 6 cycle FOLFOXIRI (irinotecan 150mg/m2, and folinic acid 400mg/m2, oxaliplatin 85 mg/m2, 5-fluorouracil 3200 mg/m2 48-h continuous infusion) for 6 cycle
• FOLFOX or CapeOX regimens
FOLFOX (oxaliplatin 85 mg/m2, and folinic acid 400 mg/m2 followed by 5-fluorouracil 400mg/m2 infusion, and 2400mg/m2 as a 46-hour continuous infusion on day 1) for 6 cycle CaoeOX (Oxaliplatin 130 mg/m2 intravenous infusion on day 1,Capecitabine 1000 mg/m2 twice daily PO for 14 days)

Locations

Country	Name	City	State
China	Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong

Sponsors (3)

Lead Sponsor	Collaborator
Nanfang Hospital, Southern Medical University	Sixth Affiliated Hospital, Sun Yat-sen University, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1. Progression-free survival	the time from randomization to relapse or death, whichever occurred first	up to 1 years
Secondary	Overall survival	the time from randomization to death from any cause	up to 5 years