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Trial Title:
Precision Chemotherapy Based on Organoid Drug Sensitivity for Colorectal Cancer
NCT ID:
NCT05832398
Condition:
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Leucovorin
Oxaliplatin
Fluorouracil
Irinotecan
Conditions: Keywords:
Organoid
Drug Test
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
FOLFOX , FOLFIRI or FOLFOXIRI regimens
Description:
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
Arm group label:
Organoid guided chemotherapy
Other name:
oxaliplatin, irinotecan, 5-fluorouracil
Intervention type:
Drug
Intervention name:
FOLFOX or CapeOX regimens
Description:
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)
Arm group label:
FOLFOX regimen
Other name:
oxaliplatin, 5-fluorouracil
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Nanfang Hospital, Southern Medical University
Address:
City:
Guangzhou
Zip:
510000
Country:
China
Status:
Recruiting
Contact:
Last name:
Jun Yan, M.D.,Ph.D
Phone:
086-13825066546
Email:
yanjunfudan@163.com
Start date:
May 1, 2023
Completion date:
December 1, 2025
Lead sponsor:
Agency:
Nanfang Hospital, Southern Medical University
Agency class:
Other
Collaborator:
Agency:
Sixth Affiliated Hospital, Sun Yat-sen University
Agency class:
Other
Collaborator:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Nanfang Hospital, Southern Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05832398
