Status:
RECRUITING
Prospective Clinical Validation of Next Generation Sequencing (NGS) and Patient-Derived Tumor Organoids (PDO) Guided Therapy in Patients with Advanced/ Inoperable Solid Tumors
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Hepatocellular Carcinoma
Colorectal Cancer
Eligibility:
All Genders
18-100 years
Phase:
PHASE3
Brief Summary
Precision oncology aims to improve clinical outcome of patients by offering personalized treatment through identifying druggable genomic aberrations within their tumors. This is particularly valid whe...
Detailed Description
Under informed consents, patients undergo tissue sampling (radiologic, endoscopic or surgical excision). DNA is extracted from tissue and sent for whole-exome sequencing (WES), organoid culture and dr...
Eligibility Criteria
Inclusion
- 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
- unable to provide informed consent
Key Trial Info
Start Date :
October 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06077591
Start Date
October 18 2024
End Date
February 1 2028
Last Update
January 27 2025
Active Locations (1)
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1
Endoscopy Centre, Prince of Wales Hospital
Hong Kong, N.T., Hong Kong, 123