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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05304741
• Other study ID #: CQGOG0501
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2023
• Source: Chongqing University Cancer Hospital
• Contact: Dongling Zou
• Phone: 13657690699
• Email: cqzl_zdl[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The study aims to establish an organoids platform and apply them to screen drugs for advanced/recurrent/metastatic colorectal cancer patients.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
China	Chongqing University Cancer Hospital	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Chongqing University Cancer Hospital

Country where clinical trial is conducted

China, 

References & Publications (7)

Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. Erratum In: CA Cancer J Clin. 2020 Jul;70(4):313. — View Citation

Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25. — View Citation

Feng RM, Zong YN, Cao SM, Xu RH. Current cancer situation in China: good or bad news from the 2018 Global Cancer Statistics? Cancer Commun (Lond). 2019 Apr 29;39(1):22. doi: 10.1186/s40880-019-0368-6. — View Citation

Kim M, Mun H, Sung CO, Cho EJ, Jeon HJ, Chun SM, Jung DJ, Shin TH, Jeong GS, Kim DK, Choi EK, Jeong SY, Taylor AM, Jain S, Meyerson M, Jang SJ. Patient-derived lung cancer organoids as in vitro cancer models for therapeutic screening. Nat Commun. 2019 Sep 5;10(1):3991. doi: 10.1038/s41467-019-11867-6. — View Citation

Narasimhan V, Wright JA, Churchill M, Wang T, Rosati R, Lannagan TRM, Vrbanac L, Richardson AB, Kobayashi H, Price T, Tye GXY, Marker J, Hewett PJ, Flood MP, Pereira S, Whitney GA, Michael M, Tie J, Mukherjee S, Grandori C, Heriot AG, Worthley DL, Ramsay RG, Woods SL. Medium-throughput Drug Screening of Patient-derived Organoids from Colorectal Peritoneal Metastases to Direct Personalized Therapy. Clin Cancer Res. 2020 Jul 15;26(14):3662-3670. doi: 10.1158/1078-0432.CCR-20-0073. Epub 2020 May 6. — View Citation

Vlachogiannis G, Hedayat S, Vatsiou A, Jamin Y, Fernandez-Mateos J, Khan K, Lampis A, Eason K, Huntingford I, Burke R, Rata M, Koh DM, Tunariu N, Collins D, Hulkki-Wilson S, Ragulan C, Spiteri I, Moorcraft SY, Chau I, Rao S, Watkins D, Fotiadis N, Bali M, Darvish-Damavandi M, Lote H, Eltahir Z, Smyth EC, Begum R, Clarke PA, Hahne JC, Dowsett M, de Bono J, Workman P, Sadanandam A, Fassan M, Sansom OJ, Eccles S, Starling N, Braconi C, Sottoriva A, Robinson SP, Cunningham D, Valeri N. Patient-derived organoids model treatment response of metastatic gastrointestinal cancers. Science. 2018 Feb 23;359(6378):920-926. doi: 10.1126/science.aao2774. — View Citation

Xie YH, Chen YX, Fang JY. Comprehensive review of targeted therapy for colorectal cancer. Signal Transduct Target Ther. 2020 Mar 20;5(1):22. doi: 10.1038/s41392-020-0116-z. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival	Progression-free survival means the duration from enrollment to disease progression or death	2 years
Primary	Overall Survival	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	3 years and 5 years
Secondary	Diagnostic Indicators	The sensitivity and specificity of organoids derived from colorectal cancer of predicting chemotherapy response of patients.	2 years