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Adjuvant Systemic Chemotherapy With or Without HAI-FUDR in Patients With Resected CRLM

NCT03500874 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2024-01-22

No results posted yet for this study

Summary

HARVEST is an investigator-initiated prospective randomized controlled study comparing adjuvant intravenous systemic chemotherapy with or without HAI- floxuridine (FUDR) in CRC patients post-liver metastasectomy.

Conditions

Interventions

DRUG

FUDR

Floxuridine(FUDR) 0.12 mg/kg/day，on Day 1-14 through the HAI pump.

DRUG

Oxaliplatin

Oxaliplatin 180 mg/m2 IV over 90 minutes on Day 1, 15.

DRUG

Leucovorin

Leucovorin 200mg/m2 ivd over 2 hours on Day 1

DRUG

5FU

5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion on Day 1.

DRUG

Irinotecan

Irinotecan 180mg/m2

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-05-28
Primary Completion
2021-08-31
Completion
2021-08-31

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 NCT03500874 on ClinicalTrials.gov