Molecular Study and Precision Medicine for Colorectal Cancer (MSPM)

Huazhong University of Science and Technology

Status

Not yet enrolling

Conditions

Advanced Colorectal Carcinoma

Recurrent Colorectal Carcinoma

Treatments

Other: Molecular Profiling & drug testing in tumor organoids and PDXs

Study type

Observational

Funder types

Other

Identifiers

NCT05883683

CIT-CoPT-R01

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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