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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05832398
Other study ID # NFEC-2022-471
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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