Drug screening using organoids from advanced colorectal cancer patients

Drug Screening of Patient-derived Organoids From Advanced/Recurrent/Metastatic Colorectal Cancer Culture to Personalized Therapy, an Exploratory Research

This study is testing how well different cancer drugs work on lab-grown mini tumors from patients with advanced colorectal cancer to see if they can improve treatment options.

Quick facts

• Study type: Observational
• Enrollment: 30 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Chongqing University Cancer Hospital (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Chongqing, Chongqing)
• Trial ID: NCT05304741 on ClinicalTrials.gov

What this trial studies

This observational study aims to establish a platform of organoids derived from patients with advanced, recurrent, or metastatic colorectal cancer. The organoids will be validated through Next Generation Sequencing (NGS) and histopathology. Following validation, drug screening assays will be conducted on these organoids using various chemotherapy and targeted agents, with the goal of comparing their sensitivity and specificity to current clinical practices.

Who should consider this trial

Good fit: Ideal candidates for this study are patients with unresectable advanced, recurrent, or metastatic colorectal cancer who have a good performance status and can comply with the research protocol.

Not a fit: Patients with severe infections, liver cirrhosis, or those who have a history of immune deficiency may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more personalized and effective treatment options for patients with advanced colorectal cancer.

How similar studies have performed: Other studies utilizing organoids for drug screening in cancer have shown promising results, indicating potential for this approach.

Eligibility criteria

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.

Where this trial is running

Chongqing, Chongqing

• Chongqing University Cancer Hospital — Chongqing, Chongqing, China (RECRUITING)

Study contacts

• Principal investigator: Dongling Zou, M.D. — Chongqing University Cancer Hospital
• Study coordinator: Dongling Zou

Conditions: Colorectal Cancer, Drug Screening, Advanced / Recurrent / Metastatic Colorectal Cancer, Orgnoids