The Culture of Advanced/Recurrent/Metastatic Colorectal Cancer Organoids and Drug Screening

Recruiting

• Conditions: Colorectal Cancer

• Registration Number: NCT05304741
• Lead Sponsor: Chongqing University Cancer Hospital

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 will be validated with a combination of Next Generation Sequencing (NGS) analysis and histopathology. Drug screening assay will be performed on organoids with the chemotherapy and targeted agents, and the sensitivity and speciality will be compared with the clinical practice.

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2022-03-20
• Study First Submitted QC: 2022-03-30
• Study First Posted: 2022-03-31
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-29
• Last Update Posted: 2023-08-31
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Patients voluntarily participated in the study and signed informed consent;
2. ECOG score 0~2;
3. Expected survival over 6 months;
4. 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;
5. CBC: Hb≥70g/L、WBC≥3.5×109/ L 、ANC≥1.5×109/L、PLT≥80×109/L；
6. Serum ALT≤2×UL, AST≤2×ULN; Serum creatinine≤1.5×ULN；
7. 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;
8. Patients can comply with the research scheme according to the judgment of the researcher.

Exclusion Criteria

1. Activity or uncontrol severe infection;
2. Liver cirrhosis, Decompensated liver disease;
3. History of immune deficiency, including HIV positive or suffering from a congenital immunodeficiency disease;
4. Chronic renal insufficiency or renal failure;
5. Other malignancies which diagnosed within 5 years or needed to be treated;
6. Myocardial infarction, severe arrhythmia and NYHA (New York heart association)≥2 for congestive heart failure
7. Concomitant diseases are treated by drugs that impair liver or kidney function, such as tuberculosis.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free Survival	2 years	Progression-free survival means the duration from enrollment to disease progression or death
Overall Survival	3 years and 5 years	Overall survival means the duration from enrollment to death due to any cause. The last follow-up time is calculated as the death time for subjects who lost follow-up

Secondary Outcome Measures

Name	Time	Method
Diagnostic Indicators	2 years	The sensitivity and specificity of organoids derived from colorectal cancer of predicting chemotherapy response of patients.

Trial Locations

Locations (1)

Chongqing University Cancer Hospital; 🇨🇳 Chongqing, Chongqing, China