Holmium-166 TARE in Liver Limited Unresectable Colorectal Cancer Patients

Sponsor
Gruppo Oncologico del Nord-Ovest
Study ID
NCT06332079
Phase
PHASE2
Status
Terminated

Conditions

  • Colorectal Cancer Metastatic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 166Holmium TARE — PROCEDURE
    166Ho-TARE treatment comprises of two hospital visits: one for a work-up procedure and another for the therapy procedure, with usually a 1-2 weeks interval.
  • Cetuximab — DRUG
    Target agent
  • Panitumumab — DRUG
    Target agent
  • 5-Fluorouracil — DRUG
    Chemotherapy
  • Bevacizumab — DRUG
    Target agent
  • Capecitabine — DRUG
    Chemotherapy

Study Details

The aim of this study is to assess the efficacy of 166Ho-TARE followed by maintenance therapy with fluoropyrimidine and anti-EGFR or bevacizumab in liver-limited unresectable colorectal cancer patients, in terms of progression free rate 9- and 8-months for cohort A and B, respectively.

Key Dates

First listed
Mar 27, 2024
Start date
Mar 13, 2024
Status verified
Dec 2025
Primary completion
Dec 16, 2025
Completion
Dec 16, 2025

Study Design

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

Arms

  • Experimental: COHORT A/B
    Eligible patients will receive Scout dose procedure. After 1-2 weeks, patients eligible for radioembolization will receive 166Ho-TARE and at least after 3 weeks, maintenance treatment with fluoropyrimidine plus target agents (anti-EGFR or bevacizumab) according to the respective study cohort. Maintenance treatment: Cohort A: * CETUXIMAB iv day1, over 1 hours, 500 mg/sqm or PANITUMUMAB iv over 1 hours, 6 mg/kg, every 14 days * LED 200 mg/sqm iv over 1 hour, day 1 * 5-FLUOROURACIL ic 48 h, starting on day 1 every 14 days; 2400 mg/sqm and 400 mg/sqm bolus if FOLFOX/FOLFIRI in the induction treatment Cohort B: * BEVACIZUMAB 5 mg/kg iv biweekly day1, over 30 minutes * LED 200 mg/sqm iv over 1 hour, day 1 * 5-FLUOROURACIL ic 48 h, starting on day 1 every 14 days; 2400 mg/sqm and 400 mg/sqm bolus if FOLFOX/FOLFIRI in the induction treatment CAPECITABINE, 1000 mg/sqm orally twice daily, day 1-14, plus bevacizumab 7,5 mg/kg iv every 21 days is allowed.

Primary Outcome Measure

Progression-free survival (PFS) Rate [ Time Frame: 36 months ]

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