Spots Global Cancer Trial Database for Holmium-166 TARE in Liver Limited Unresectable Colorectal Cancer Patients

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Trial Identification

Brief Title: Holmium-166 TARE in Liver Limited Unresectable Colorectal Cancer Patients

Official Title: 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

Study ID: NCT06332079

Conditions

Colorectal Cancer Metastatic

Interventions

Study Description

Brief 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).