Treatment of Colorectal Liver Metastases With Immunotherapy and Bevacizumab

Sponsor
Asan Medical Center
Study ID
NCT03698461
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Atezolizumab — DRUG
    * 1200mg IV on day1 before start of cycle 'atezolizuamb, bevacizumab + FOLFOX(Oxaliplatin, Levoleucovorin, 5-FU') * 840mg IV D1 of C1-12 (Cycle: every 2 weeks)
  • Bevacizumab — DRUG
    5mg/kg IV D1 of C1-12 (Cycle: every 2 weeks) at least 5 minutes after completion of atezolizumab
  • Oxaliplatin — DRUG
    85mg/m2 IV D1 of C1-12 (Cycle: every 2 weeks)
  • Levoleucovorin — DRUG
    200mg/m2 IV D1 of C1-12 (Cycle: every 2 weeks)
  • 5-FU — DRUG
    * 5-FU Bolus: 400mg/m2 IV bolus D1 of C1-12 (Cycle: every 2 weeks) * 5-FU infusion: 2400mg/mg continuous IV infusion over 46hours D1-3 of C1-12 (Cycle: every 2 weeks)

Study Details

Liver is the most common site of metastases from colorectal cancer. Neoadjuvant chemotherapy with targeted agents is usually recommended for borderline-resectable liver metastases that are technically difficult to resect for conversion to resectable disease and control of metastatic spread. However, the prognosis of these patients are still poor, and long term disease-free survival over 3 years is rare and \<20%. More effective measures to prevent recurrence are needed before or after resection of colorectal liver metastases.

Key Dates

Start date
May 15, 2019
Status verified
Jan 2024
Primary completion
Dec 22, 2021
Completion
Oct 24, 2023

Study Design

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

Arms

  • Experimental: Atezolizumab, Bevacizumab, FOLFOX
    Atezolizumab 1200mg IV Once, Atezolizumab (840mg IV D1 of C1-12) + Bevacizumab (5mg/kg IV D1 of C1-12) + FOLFOX(Oxaliplatin 85mg/m2 IV D1 of C1-12, Levoleucovorin 200mg/m2 IV D1 of C1-12, 5-FU - bolus 400mg/m2 IV D1 of C1-12, - infusional 2400mg/m2 IV continuous(46 hours) D1-3 of C1-12)

Primary Outcome Measure

Serial changes in Cluster of Differentiation(CD) 8+ T cell densities [ Time Frame: Baseline, Day15 of first atezolizumab administration, and after at least 6 cycles (each cycle is 14days) ]

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