Personalized chemotherapy for advanced colorectal cancer using organoid testing
Precision Chemotherapy Based on Organoid for Colorectal CancerPatient-Derived Tumor Organoid Drug Sensitivity for Colorectal Cancer: A Prospective, Multicentre，Randomized, Controlled Trial
This study is testing if personalized chemotherapy based on lab-grown mini tumors can help people with advanced colorectal cancer live longer without their disease getting worse.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 186 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Nanfang Hospital, Southern Medical University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05832398 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of chemotherapy tailored to individual patients with stage IV colorectal cancer based on drug sensitivity tests conducted on patient-derived tumor organoids. The standard treatment involves fluorouracil-based chemotherapy, but its effectiveness is often limited. By using organoids to predict how patients will respond to different chemotherapy regimens, the study aims to validate whether this personalized approach can lead to improved progression-free survival (PFS) outcomes. The trial will involve administering various chemotherapy regimens, including FOLFOX and FOLFIRI, based on the organoid testing results.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with histologically confirmed stage IV colorectal cancer who are eligible for chemotherapy.
Not a fit: Patients who refuse chemotherapy or have severe organ damage may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients with advanced colorectal cancer.
How similar studies have performed: Other studies have shown promise in using organoid models for predicting drug response, suggesting this approach could be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Guangzhou, Guangdong
- Nanfang Hospital, Southern Medical University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Jun Yan, M.D., Ph.D — Nanfang Hospital, Southern Medical University
- Study coordinator: Jun Yan, M.D., Ph.D
- Email: yanjunfudan@163.com
- Phone: 086-13825066546
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.