Precision Medicine for Advanced or Recurrent Colorectal Cancer Directed by High-throughput Sequencing and Tumor Organoids Model
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Advanced Colorectal Carcinoma
- Sponsor
- Wuhan Union Hospital, China
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Identification of effective drugs or drug combinations
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
Researchers collect specimens from advanced or recurrent colorectal cancer (CRC) patients to conduct molecular profiling and establish tumor organoids (PDOs)/ patient-derived xenografts (PDXs). The aim of this study is to identify clinical actionable targets and predict in vivo response of the tumor to targeted drugs by using PDOs/ PDXs. And the above-mentioned studies will provide the patients with potential personalized cancer treatment options.
Detailed Description
Patient-derived organoid is a model that can recapitulate the histology and behavior of the cancer from which it is derived, and is increasingly used as a tool for drug development in pre-clinical settings. Clinical treatment option of colorectal cancer now is quite limited. By molecular profiling, clinical actionable alterations may be identified. And according to the genomic investigation results, we can find the matched targeted drugs, following further testing in the organoids and PDXs. This will provide an opportunity to guide the precision medicine.
Investigators
Zheng Wang, MD/PhD
Study chair, Clinical Professor
Wuhan Union Hospital, China
Eligibility Criteria
Inclusion Criteria
- •Male or female patients, age 18 to 75 years old
- •Patients with a documented (histologically- or cytologically-proven) advanced or recurrent colorectal cancer
- •Patients must have Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 and a life expectancy of at least 3 months
- •Patients, both male and female, who are either not of childbearing potential or who agree to use a medically effective method of contraception during the study and for 3 months after the last dose of study drug.
- •Patients with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol.
Exclusion Criteria
- •Patients with any other life-threatening illness, significant organ system dysfunction, or clinically significant laboratory abnormality, which, in the opinion of the Investigator, would either compromise the patient's safety or interfere with evaluation of the safety of the study drug
- •Patients with abnormal coagulation function, bleeding tendency, or receiving thrombolytic or anticoagulant therapy
- •Patients with any other serious/active/uncontrolled infection, any infection requiring parenteral antibiotics, or unexplained fever \> 38ºC within 2 weeks prior to first study drug administration.
- •Patients with a history of human immunodeficiency virus (HIV) or any other immunodeficiency disease.
- •Patients who are currently using certain drugs that are not permitted
- •Patients with a psychiatric disorder or altered mental status that would preclude understanding of the informed consent process and/or completion of the necessary studies
- •Patients with the inability, in the opinion of the Investigator, to comply with the protocol requirements
Outcomes
Primary Outcomes
Identification of effective drugs or drug combinations
Time Frame: up to 3 years
Viability of organoid is measured using CellTiter-Glo by quantifying ATP, which indicates the presence of metabolically active cells.
Secondary Outcomes
- Correlation between organoid and PDX drug sensitivities(Up to 3 years)
- Comparison of clinical actionable alterations identified in native tumor and organoids.(Up to 3 years)