NCT05832398

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
186

participants targeted

Target at P50-P75 for not_applicable colorectal-cancer

Timeline
Completed

Started May 2023

Typical duration for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 27, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

June 28, 2023

Status Verified

June 1, 2023

Enrollment Period

1.7 years

First QC Date

February 6, 2023

Last Update Submit

June 27, 2023

Conditions

Colorectal Cancer

Keywords

OrganoidDrug Test

Outcome Measures

Primary Outcomes (1)

  • 1. Progression-free survival

    the time from randomization to relapse or death, whichever occurred first

    up to 1 years

Secondary Outcomes (1)

  • Overall survival

    up to 5 years

Study Arms (2)

Organoid guided chemotherapy

EXPERIMENTAL

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 regimen

ACTIVE COMPARATOR

Patients will receive FOLFOX regimen once every two weeks for 6 cycles as adjuvant chemotherapy

Drug: FOLFOX or CapeOX regimens

Interventions

FOLFOX , FOLFIRI or FOLFOXIRI regimensDRUG

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

Also known as: oxaliplatin, irinotecan, 5-fluorouracil
Organoid guided chemotherapy
FOLFOX or CapeOX regimensDRUG

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)

Also known as: oxaliplatin, 5-fluorouracil
FOLFOX regimen

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Folfox protocolOxaliplatinIrinotecanFluorouracil

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsCamptothecinAlkaloidsHeterocyclic CompoundsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Jun Yan, M.D., Ph.D

    Nanfang Hospital, Southern Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Yan, M.D., Ph.D

CONTACT

086-13825066546yanjunfudan@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2023

First Posted

April 27, 2023

Study Start

May 1, 2023

Primary Completion

January 1, 2025

Study Completion

December 1, 2025

Last Updated

June 28, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)