Precision Chemotherapy Based on Organoid Drug Sensitivity for Colorectal Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: FOLFOX , FOLFIRI or FOLFOXIRI regimens
* Drug: FOLFOX or CapeOX regimens


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Organoid guided chemotherapy<br>Patients will receive sensitive chemotherapy in organoid drug test once every two weeks for 6 cycles as adjuvant chemotherapy | Drug: FOLFOX , FOLFIRI or FOLFOXIRI regimens<br>* 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<br>* Other names: oxaliplatin, irinotecan, 5-fluorouracil;|
| Active Comparator: FOLFOX regimen<br>Patients will receive FOLFOX regimen once every two weeks for 6 cycles as adjuvant chemotherapy | Drug: FOLFOX or CapeOX regimens<br>* 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)<br>* Other names: oxaliplatin, 5-fluorouracil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Progression-free survival | the time from randomization to relapse or death, whichever occurred first | up to 1 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | the time from randomization to death from any cause | up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Organoid, Drug Test