A Study of Bevacizumab Plus XELOX/XELIRI for First-line Treatment in Unresectable Advanced Colorectal Cancer

Sponsor
Jiangsu Cancer Institute & Hospital
Study ID
NCT04324476
Phase
PHASE2
Status
Unknown

Conditions

  • Advanced Colorectal Cancer

Eligibility Criteria

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

Interventions

Study Details

The objective is to investigate the efficacy and safety of two-weekly alternative regimen of Bevacizumab plus XELOX/XELIRI for First-line Treatment in Unresectable Advanced Colorectal Cancer.

Key Dates

Start date
Sep 1, 2019
Status verified
Aug 2021
Primary completion
Jul 31, 2022
Completion
Jun 30, 2023

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Alternating Bevacizumab plus XELOX and Bevacizumab plus XELIRI
    Induction chemotherapy: Alternating Bevacizumab plus XELOX and Bevacizumab plus XELIRI: Bevacizumab: 5mg/kg, iv, 30min, d1, 2w; Oxaliplatin: 85mg/㎡, iv, 120min, d1, 4w; Irinotecan: 150mg/㎡, iv, 90min, d15, 4w; Capecitabine: 1000mg/㎡, bid, d2-8, 2w. Maintenance chemotherapy: Bevacizumab: 7.5mg/kg, iv, 30min, d1, q3w; Capecitabine: 1000mg/㎡, bid, d2-15, 2w.

Primary Outcome Measure

Progression Free Survival 1 (PFS 1) [ Time Frame: 28 months ]

Central Contacts

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