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Precision Chemotherapy Based on Organoid Drug Sensitivity for Colorectal Cancer

NCT05832398 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2023-06-28

No results posted yet for this study

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.

Conditions

Interventions

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

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)

Sponsors & Collaborators

  • Sixth Affiliated Hospital, Sun Yat-sen University

    collaborator OTHER

  • Sun Yat-sen University

    collaborator OTHER

  • Nanfang Hospital, Southern Medical University

    lead OTHER

Principal Investigators

  • Jun Yan, M.D., Ph.D · Nanfang Hospital, Southern Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-01
Primary Completion
2025-01-01
Completion
2025-12-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05832398 on ClinicalTrials.gov