Precision Chemotherapy Based on Organoid Drug Sensitivity for Colorectal Cancer

Precision Chemotherapy Based on Organoid for Colorectal CancerPatient-Derived Tumor Organoid Drug Sensitivity for Colorectal Cancer: A Prospective, Multicentre，Randomized, Controlled Trial

The purpose of this study is to investigate whether chemotherapy guided by patient-derived tumor organoid drug test can improve the outcomes of stage IV colorectal cancer.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: FOLFOX , FOLFIRI or FOLFOXIRI regimens; Drug: FOLFOX or CapeOX regimens

Detailed Description

Fluorouracil-based chemotherapy is the standard treatment for stage IV colorectal cancer patients. However, the effects of chemotherapy remains limited. Patient-derived tumor organoids are increasingly used as tools for drug test and predicting drug response in the clinic, and have been showed to faithfully predict clinical outcomes of patients with CRC. A prospective clinical trial is needed to validate whether the in vitro sensitivity to chemotherapy regimens in organoids drug test is associated with a longer PFS in stage IV colorectal cancer.

• Study Type: Interventional
• Enrollment (Estimated): 186
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jun Yan, M.D., Ph.D; Phone Number: 086-13825066546; Email: yanjunfudan@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Nanfang Hospital, Southern Medical University
      • Contact: Jun Yan, M.D.,Ph.D; Phone Number: 086-13825066546; Email: yanjunfudan@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age between 18 and 70
• Histological confirmed colorectal cancer
• Stage IV
• American Society of Anesthesiologists (ASA) score I~III
• No contraindication for chemotherapy
• No evidence of other malignant tumor

Exclusion Criteria:

• Refusing chemotherapy
• Pregnant or breast-feeding women
• Severe organ damage after chemotherapy, surgery or unable to continue to systemic chemotherapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Organoid guided chemotherapy; Patients will receive sensitive chemotherapy in organoid drug test once every two weeks for 6 cycles as adjuvant chemotherapy	Drug: FOLFOX , FOLFIRI or FOLFOXIRI regimens; FOLFOX (oxaliplatin 85 mg/m2, and folinic acid 400 mg/m2 followed by 5-fluorouracil 400mg/m2 infusion, and 2400mg/m2 as a 46-hour continuous infusion on day 1) for 6 cycle FOLFIRI (irinotecan 150 mg/m2, and folinic acid 400 mg/m2 followed by 5-fluorouracil 400mg/m2 infusion, and 2400mg/m2 as a 46-hour continuous infusion on day 1) for 6 cycle FOLFOXIRI (irinotecan 150mg/m2, and folinic acid 400mg/m2, oxaliplatin 85 mg/m2, 5-fluorouracil 3200 mg/m2 48-h continuous infusion) for 6 cycle; Other Names: oxaliplatin, irinotecan, 5-fluorouracil
Active Comparator: FOLFOX regimen; Patients will receive FOLFOX regimen once every two weeks for 6 cycles as adjuvant chemotherapy	Drug: FOLFOX or CapeOX regimens; FOLFOX (oxaliplatin 85 mg/m2, and folinic acid 400 mg/m2 followed by 5-fluorouracil 400mg/m2 infusion, and 2400mg/m2 as a 46-hour continuous infusion on day 1) for 6 cycle CaoeOX (Oxaliplatin 130 mg/m2 intravenous infusion on day 1,Capecitabine 1000 mg/m2 twice daily PO for 14 days); Other Names: oxaliplatin, 5-fluorouracil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. Progression-free survival	the time from randomization to relapse or death, whichever occurred first	up to 1 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	the time from randomization to death from any cause	up to 5 years

Collaborators and Investigators

• Sponsor: Nanfang Hospital, Southern Medical University
• Collaborators: Sun Yat-sen University; Sixth Affiliated Hospital, Sun Yat-sen University
• Investigators: Principal Investigator: Jun Yan, M.D., Ph.D, Nanfang Hospital, Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: February 6, 2023
• First Submitted That Met QC Criteria: April 26, 2023
• First Posted (Actual): April 27, 2023

Study Record Updates

• Last Update Posted (Actual): June 28, 2023
• Last Update Submitted That Met QC Criteria: June 27, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Organoid; Drug Test
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Protective Agents; Topoisomerase Inhibitors; Micronutrients; Vitamins; Topoisomerase I Inhibitors; Antidotes; Vitamin B Complex; Fluorouracil; Oxaliplatin; Leucovorin; Irinotecan
• Other Study ID Numbers: NFEC-2022-471

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No