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FUDR/Oxaliplatin HAI Plus Irinotecan vs. FOLFOXIRI Chemotherapy in Treating Initially Unresectable CRCLM

NCT03678428 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2023-02-16

No results posted yet for this study

Summary

The aim of the trial is to compare the objective response rates of FUDR/Oxaliplatin HAI plus CPT-11 and FOLFOXIRI chemotherapy in patients with initially non-resectable metastatic colorectal cancer liver metastases. The patients will be treated with systemic FOLFOXIRI chemotherapy or FUDR/Oxaliplatin hepatic arterial infusion with CPT-11 systemic chemotherapy.

Conditions

Interventions

DRUG

Irinotecan

Irinotecan 150 mg/m2 IV over 90 minutes on Day 1 and 15.

DRUG

Oxaliplatin HAI

Oxaliplatin 85 mg/m2 over 3 hours will be administered through the HAI pump on day 1. Oxaliplatin 85 mg/m2 IV over 3 hours on day 15.

DRUG

Floxuridine

0.12 mg/kg/day floxuridine (FUDR) and 25 mg dexamethasone in normal saline to a total volume of 300 ml will be administered through the HAI pump.

DRUG

Leucovorin

Leucovorin 200mg/m2 IV on Day 1 and 15.

DRUG

5-FU

5-FU 2400mg/m2 CIV in 46h on Day 1 and 15.

DRUG

Oxaliplatin

Oxaliplatin 85 mg/m2 IV over 3 hours on Day1 and 15.

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Yuhong Li, MD · Sun Yat-sen 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
2021-12-31
Primary Completion
2022-10-31
Completion
2022-12-31

Countries

  • China

Study Locations

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Entities

Drugs
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 NCT03678428 on ClinicalTrials.gov