NCT06332079

Holmium-166 TARE in Liver Limited Unresectable Colorectal Cancer Patients

Phase II Study Evaluating Holmium-166 TARE Followed by Maintenance Therapy in Liver Limited Unresectable Colorectal Cancer Patients After First-line Chemotherapy and Target Agents

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Gruppo Oncologico del Nord-Ovest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

HAITI is a phase II, single-arm trial of 166Ho-TARE followed by maintenance therapy in liver-limited unresectable colorectal cancer patients, achieving partial response or stable disease according to RECIST 1.1 criteria after 6-12 cycles of induction first-line chemotherapy. Two cohorts of patients are included: * left sided RAS/BRAF wild-type (cohort A) * right-sided and/or RAS mutated (cohort B) Enrolled patients will be treated with different maintenance therapy according to study cohort (fluoropyrimidine + anti-EGFR or bevacizumab).

Conditions

• Colorectal Cancer Metastatic

Interventions

Type	Name	Description
PROCEDURE	166Holmium TARE	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.
DRUG	Cetuximab	Target agent
DRUG	Panitumumab	Target agent
DRUG	5-Fluorouracil	Chemotherapy
DRUG	Bevacizumab	Target agent
DRUG	Capecitabine	Chemotherapy

Timeline

• Start date: 2024-03-13
• Primary completion: 2025-12-16
• Completion: 2025-12-16
• First posted: 2024-03-27
• Last updated: 2026-01-05

Locations

1 site across 1 country: Italy