Status:
UNKNOWN
The Culture of Advanced/Recurrent/Metastatic Colorectal Cancer Organoids and Drug Screening
Lead Sponsor:
Chongqing University Cancer Hospital
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-70 years
Brief Summary
The study aims to establish an organoids platform and apply them to screen drugs for advanced/recurrent/metastatic colorectal cancer patients.
Detailed Description
The study was designed as a prospective, observational clinical trial in a single center. We establish organoids derived from patients with advanced/recurrent/metastatic colorectal cancer. Organoids w...
Eligibility Criteria
Inclusion
- Patients voluntarily participated in the study and signed informed consent;
- ECOG score 0\~2;
- Expected survival over 6 months;
- The serum or urine pregnancy test must be negative within 7 days before enrollment for the women of childbearing age who should agree that contraception must be used during the trial;
- CBC: Hb≥70g/L、WBC≥3.5×109/ L 、ANC≥1.5×109/L、PLT≥80×109/L；
- Serum ALT≤2×UL, AST≤2×ULN; Serum creatinine≤1.5×ULN；
- Colorectal cancer was unresectable and confirmed as adenocarcinoma by histopathology. Patients have no significant symptoms in the primary lesion (no bleeding, perforation and obstruction in the primary focus). Besides, the carcinoma is potentially resectable but the patient refuses surgery;
- Patients can comply with the research scheme according to the judgment of the researcher.
Exclusion
- Activity or uncontrol severe infection;
- Liver cirrhosis, Decompensated liver disease;
- History of immune deficiency, including HIV positive or suffering from a congenital immunodeficiency disease;
- Chronic renal insufficiency or renal failure;
- Other malignancies which diagnosed within 5 years or needed to be treated;
- Myocardial infarction, severe arrhythmia and NYHA (New York heart association)≥2 for congestive heart failure
- Concomitant diseases are treated by drugs that impair liver or kidney function, such as tuberculosis.
Key Trial Info
Start Date :
January 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05304741
Start Date
January 1 2020
End Date
December 31 2023
Last Update
August 31 2023
Active Locations (1)
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1
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China, 400000