FOLFOX Via HAI Plus Intravenous Irinotecan With or Without Bevacizumab Versus Systemic FOLFOXIRI With or Without Bevacizumab in Initially Unresectable RAS-mutated CRLM Patients

Sponsor
Sun Yat-sen University
Study ID
NCT05727163
Phase
PHASE2
Status
Recruiting
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Conditions

  • Colorectal Cancer Metastatic

Eligibility Criteria

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

Interventions

  • Dexamethasone — DRUG
    25mg via HAI (Pre-chemotherapy)
  • Anisodamine — DRUG
    10 mg via HAI (Pre-chemotherapy)
  • Oxaliplatin — DRUG
    85 mg/m2 via HAI over 3 hours
  • Leucovorin — DRUG
    200 mg/m2 via HAI
  • Fluorouracil — DRUG
    400 mg/m2 via HAI and 2.4g/m2 via HAI over 48 hours
  • Irinotecan — DRUG
    150 mg/m2 intravenously
  • Bevacizumab — DRUG
    5 mg/kg intravenously
  • Oxaliplatin — DRUG
    85 mg/m2 intravenously over 3 hours
  • Leucovorin — DRUG
    200 mg/m2 intravenously
  • Fluorouracil — DRUG
    400 mg/m2 intravenously + 2400 mg/m2 continuous intravenous infusion over 46 hours

Study Details

This prospective, randomized, controlled clinical study aims to evaluate the objective remission rate of FOLFOX hepatic artery infusion chemotherapy (HAI) in combination with systemic irinotecan with or without bevacizumab versus systemic intravenous FOLFOXIRI with or without bevacizumab in initially unresectable RAS-mutated colorectal cancer patients with liver metastases.

Key Dates

Start date
Jul 29, 2022
Status verified
May 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

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

Arms

  • Experimental: HAI group
    FOLFOX given via Hepatic Artery Infusion (HAI) in Combination With intravenous Irinotecan With or Without Bevacizumab. Dexamethasone 25 mg via HAI (Pre-chemotherapy) Anisodamine (654-2) 10 mg HAI (Pre-chemotherapy) Oxaliplatin 85 mg/m2 via HAI over 3 hours Leucovorin 200 mg/m2 via HAI FU 400 mg/m2 via HAI FU 2.4g/m2 via HAI over 48 hours Irinotecan 150 mg/m2 intravenously Bevacizumab 5 mg/kg intravenously The above regimen was given on Day 1 and repeated after 14 days. Patients will typically receive a maximum of 12 courses (preoperative and/or postoperative) unless disease progression is detected, intolerable adverse effects, or the patient refuses further treatment.
  • Active Comparator: Systemic Chemotherapy group
    Systemic FOLFOXIRI With or Without Bevacizumab Irinotecan 150mg/m2 intravenously Oxaliplatin 85 mg/m2 intravenously over 3 hours Leucovorin 200 mg/m2 intravenously FU 400 mg/m2 intravenously 5-FU 2400 mg/m2 continuous intravenous infusion over 46 hours Bevacizumab 5 mg/kg intravenously Note: (UGT\*28 7/7, UGT\*6 A/A, UGT\*28 6/7 and UGT\*6 A/G patients, Irinotecan dosage was reduced to 130 mg/m2) The above regimen was given on Day 1 and repeated after 14 days. Patients will typically receive a maximum of 12 courses (preoperative and/or postoperative) unless disease progression is detected, intolerable adverse effects, or the patient refuses further treatment.

Primary Outcome Measure

Objective Remission Rate (ORR) [ Time Frame: Assessed up to 48 months ]

Central Contacts

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