Organoid-Guided Chemotherapy for Stage IV Colorectal Cancer

Sponsor

Nanfang Hospital of Southern Medical University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05832398

Collaborator

Sixth Affiliated Hospital, Sun Yat-sen University (Other), Sun Yat-sen University (Other)

446

Enrollment

Location

Arms

Anticipated Duration (Months)

14.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Drug: FOLFOX , FOLFIRI or FOLFOXIRI regimens Drug: FOLFOX regimen	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

446 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Patient-Derived Tumor Organoid-Guided Chemotherapy Versus Standard Chemotherapy for Stage IV Colorectal Cancer: A Prospective, Randomized, Controlled Trial

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

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 regimen 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 Other Names: oxaliplatin, 5-fluorouracil

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 regimen

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

Other Names:

oxaliplatin, 5-fluorouracil

Outcome Measures

Primary Outcome Measures

1. Progression-free survival [up to 1 years]
the time from randomization to relapse or death, whichever occurred first

Secondary Outcome Measures

Overall survival [up to 5 years]
the time from randomization to death from any cause

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong	China	510000

Sponsors and Collaborators

Nanfang Hospital of Southern Medical University
Sixth Affiliated Hospital, Sun Yat-sen University
Sun Yat-sen University

Investigators

Principal Investigator: Jun Yan, M.D., Ph.D, Nanfang Hospital of Southern Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nanfang Hospital of Southern Medical University

ClinicalTrials.gov Identifier:

NCT05832398

Other Study ID Numbers:

NFEC-2022-471

First Posted:

Apr 27, 2023

Last Update Posted:

Apr 27, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Nanfang Hospital of Southern Medical University

Organoid

Drug Test

Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 27, 2023