Back to resultsPrecision Chemotherapy Based on Organoid Drug Sensitivity for Colorectal Cancer
Primary Purpose
Colorectal Cancer
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
FOLFOX , FOLFIRI or FOLFOXIRI regimens
FOLFOX or CapeOX regimens
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring Organoid, Drug Test
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
Sites / Locations
- Nanfang Hospital, Southern Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Organoid guided chemotherapy
FOLFOX regimen
Arm Description
Patients will receive sensitive chemotherapy in organoid drug test once every two weeks for 6 cycles as adjuvant chemotherapy
Patients will receive FOLFOX regimen once every two weeks for 6 cycles as adjuvant chemotherapy
Outcomes
Primary Outcome Measures
1. Progression-free survival
the time from randomization to relapse or death, whichever occurred first
Secondary Outcome Measures
Overall survival
the time from randomization to death from any cause
Full Information
NCT ID
NCT05832398
First Posted
February 6, 2023
Last Updated
June 27, 2023
Sponsor
Nanfang Hospital, Southern Medical University
Collaborators
Sixth Affiliated Hospital, Sun Yat-sen University, Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT05832398
Brief Title
Precision Chemotherapy Based on Organoid Drug Sensitivity for Colorectal Cancer
Official Title
Precision Chemotherapy Based on Organoid for Colorectal CancerPatient-Derived Tumor Organoid Drug Sensitivity for Colorectal Cancer: A Prospective, Multicentre，Randomized, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanfang Hospital, Southern Medical University
Collaborators
Sixth Affiliated Hospital, Sun Yat-sen University, Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Organoid, Drug Test
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
186 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Organoid guided chemotherapy
Arm Type
Experimental
Arm Description
Patients will receive sensitive chemotherapy in organoid drug test once every two weeks for 6 cycles as adjuvant chemotherapy
Arm Title
FOLFOX regimen
Arm Type
Active Comparator
Arm Description
Patients will receive FOLFOX regimen once every two weeks for 6 cycles as adjuvant chemotherapy
Intervention Type
Drug
Intervention Name(s)
FOLFOX , FOLFIRI or FOLFOXIRI regimens
Other Intervention Name(s)
oxaliplatin, irinotecan, 5-fluorouracil
Intervention 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
Intervention Type
Drug
Intervention Name(s)
FOLFOX or CapeOX regimens
Other Intervention Name(s)
oxaliplatin, 5-fluorouracil
Intervention 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)
Primary Outcome Measure Information:
Title
1. Progression-free survival
Description
the time from randomization to relapse or death, whichever occurred first
Time Frame
up to 1 years
Secondary Outcome Measure Information:
Title
Overall survival
Description
the time from randomization to death from any cause
Time Frame
up to 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Yan, M.D., Ph.D
Phone
086-13825066546
Email
yanjunfudan@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Yan, M.D., Ph.D
Organizational Affiliation
Nanfang Hospital, Southern Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanfang Hospital, Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Yan, M.D.,Ph.D
Phone
086-13825066546
Email
yanjunfudan@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Precision Chemotherapy Based on Organoid Drug Sensitivity for Colorectal Cancer
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