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A Study of Systemic Chemotherapy With CPT-11 Plus HAI (FUDR+L-OHP) in Patients With Initially Unresectable CRCLM

NCT03493061 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-02-15

No results posted yet for this study

Summary

The aim of the trial is to optimize response rates and rates of secondary resections of metastases in patients with initially non-resectable metastatic colorectal cancer Liver Metastasis. The patients will be treated with systemic chemotherapy With irinotecan plus hepatic arterial infusion With floxuridine and oxaliplatin

Conditions

  • Colo-rectal Cancer
  • Liver Metastases

Interventions

DRUG

Irinotecan

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

DRUG

Oxaliplatin

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.

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2018-02-01
Primary Completion
2020-12-30
Completion
2022-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT03493061 on ClinicalTrials.gov