Phase II Study Comparing Conversion Rate to Surgery With Hepatic Arterial Infusion Chemotherapy to Systemic Chemotherapy in Patients With Non Resectable Liver-only Colorectal Metastases

Sponsor
Yonsei University
Study ID
NCT05103020
Phase
PHASE2
Status
Unknown

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

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

Interventions

Study Details

Approximately 40% of colorectal cancer patients will develop colorectal liver metastases (CRLM). The most effective approach to increase long-term survival is CRLM complete resection. Unfortunately, only 10 - 15% of CRLM are initially considered resectable. The objective response rates (ORR) after current first-line systemic chemotherapy (sys-CT) regimens range from 40 to 80% and complete resection rates (CRR) range from 25 to 50% in patients with initially unresectable CRLM. When CRLM patients are not amenable to complete resection after induction of sys-CT, ORRs obtained with second-line sys-CT are much lower (between 10 and 30%) and consequently CRRs are also low (\< 10%). Hepatic arterial infusion (HAI) oxaliplatin may represent a salvage therapy in patients with CRLM unresectable after one or more sys-CT regimens with ORRs and CRRs up to 60 and 30%, respectively. This study is designed to evaluate the efficacy of an intensification strategy based on HAI oxaliplatin combined with sys-CT as the first-line treatment in patients with unresectable CRLM.

Key Dates

First listed
Nov 2, 2021
Start date
Nov 1, 2021
Status verified
Nov 2021
Primary completion
Mar 31, 2023
Completion
Mar 31, 2025

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HAI oxaliplatin and systemic FOLFIRI plus targeted therapy (bevacizumab or cetuximab)
    HAI-oxaliplatin + Systemic FOLFIRI + target agent (bevacizumab or cetuximab)
  • Active Comparator: Systemic FOLFIRI plus targeted therapy (bevacizumab or cetuximab)
    IV FOLFIRI+ target agent (bevacizumab or cetuximab)

Primary Outcome Measure

curative-intent resection rate [ Time Frame: Every 4 cycles of chemotherapy (approximately 24 months) (each cycle is 2weeks) ]

Central Contacts

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