About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
patients with advanced or recurrent colorectal cancer
Trial design
Cohort
Prospective
Treatments tested in this trial
Molecular Profiling & drug testing in tumor organoids and PDXs
Other interventionMolecular profiling of native tumor will be performed and analyzed by using a self-designed panel. Tumor organoids will be cultured from fresh tumor tissues and patient-derived xenografts model will be established using the tumor organoids. Drugs will be tested in the two models. And the recommendation will be communicated to the clinicians.
Treatment groups
Trial outcomes
Primary outcomes
Identification of effective drugs or drug combinations
Viability of organoid is measured using CellTiter-Glo by quantifying ATP, which indicates the presence of metabolically active cells.
Secondary outcomes
Comparison of clinical actionable alterations identified in native tumor and organoids.
Genomic gene mutation numbers are identified using the Next-Generation Sequencing (NGS).
Correlation between organoid and PDX drug sensitivities
Size of the tumor is measured to reflect the drug response.
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: