Personalized treatment using patient-derived tumor organoids for advanced solid tumors
Prospective Clinical Validation of Next Generation Sequencing (NGS) and Patient-Derived Tumor Organoids (PDO) Guided Therapy in Patients With Advanced/ Inoperable Solid Tumors
This study is testing a new way to personalize cancer treatment by using samples from patients' tumors to find the best drugs for those with advanced liver and colorectal cancers that haven't responded to regular treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 1 site (Hong Kong, N.T.) |
| Trial ID | NCT06077591 on ClinicalTrials.gov |
What this trial studies
This clinical trial focuses on precision oncology by utilizing next-generation sequencing and patient-derived tumor organoids to guide therapy for patients with advanced or inoperable solid tumors, specifically hepatocellular carcinoma and colorectal cancer. Patients will undergo tissue sampling for DNA extraction, which will then be analyzed through whole-exome sequencing to identify genomic aberrations. The generated organoids will be tested for drug sensitivity, allowing for personalized treatment options based on individual tumor profiles. The goal is to provide alternative therapies for patients who have not responded to standard treatments.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with metastatic, inoperable, or advanced solid tumors that are refractory to at least one standard chemotherapy or targeted therapy.
Not a fit: Patients who are unable to provide informed consent or have tumors that are not accessible for biopsy or resection may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients with advanced solid tumors by offering tailored therapies based on their unique tumor characteristics.
How similar studies have performed: Previous observational studies have shown promising results with patient-derived organoids in predicting treatment responses, indicating potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients with metastatic, inoperable or advanced solid tumors who are refractory to at least one standard chemo- or targeted drugs. * The disease is accessible for a biopsy (radiologic or endoscopic) or resection of a metastatic site. * These patients are seen at a multidisciplinary tumor board meeting prior to referrals. * aged \>18 years, able to provide written consents to trial participation, * with an Eastern cooperative oncology group performance status of 0 or 1, * with measurable disease in accordance with response evaluation criteria in solid tumors (RECIST) version 1.1. * deem suitable for standard chemo-therapy; i.e. with a normal neutrophil count, hemoglobin \> 9g/dl, serum creatinine, \<1.5 x upper limit of normal, bilirubin \< 1.5 x normal, Aspartate and alanine aminotransferases (\<3 x ULN or \<5x * those with liver metastasis) and with an ejection Fraction \>50% of normal on echocardiography. Exclusion Criteria: * unable to provide informed consent
Where this trial is running
Hong Kong, N.T.
- Endoscopy Centre, Prince of Wales Hospital — Hong Kong, N.t., Hong Kong (Recruiting)
Study contacts
- Principal investigator: James Lau — Prince of Wales Hospital
- Study coordinator: James Lau, MD
- Email: laujyw@surgery.cuhk.edu.hk
- Phone: 35051445
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.