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

Sponsor
Sun Yat-sen University
Study ID
NCT03493061
Phase
PHASE2
Status
Completed

Conditions

  • Colo-rectal Cancer
  • Liver Metastases

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan — DRUG
    Irinotecan 150 mg/m2 IV over 90 minutes on Day 1, 15
  • Oxaliplatin — DRUG
    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.
  • Floxuridine — DRUG
    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.

Study Details

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

Key Dates

Start date
Feb 1, 2018
Status verified
Feb 2023
Primary completion
Dec 30, 2020
Completion
Dec 30, 2022

Study Design

Enrollment
60 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Systemic CPT-11 + HAI (FUDR+L-OHP)
    Patients will receive Systemic CPT-11 + HAI (FUDR+L-OHP) every 28 days: Irinotecan 150 mg/m2 IV over 90 minutes on Day 1; followed by Oxaliplatin 85 mg/m2 over 3 hours through the HAI pump on Day 1 and 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. then Irinotecan 150 mg/m2 IV over 90 minutes on Day 15, followed by Oxaliplatin 85 mg/m2 IV over 3 hours on Day 15. This will be repeated on Day 1 of each 28-day cycle. FUDR will be administered through a 14-day continuous infusion with the HAI pump.

Primary Outcome Measure

Complete resection rates (R0 resection rates) [ Time Frame: Up to 2-4 months ]

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