The objective is to evaluate the efficacy and safety of reintroduction of modified XELOXIRI combined with molecular targeted drug in patients with metastatic colorectal cancer (mCRC)
It is an investigator-initiated, single institution, prospective, single-arm clinical study to evaluate the efficacy and safety of reintroduction of modified XELOXIRI combined with bevacizumab as first-line therapy in patients with unresectable mCRC. Eligible patients will receive 12 cycles of mXELOXIRI with bevacizumab and then MDT will be initiated to determine whether to perform a surgery or receive the maintenance therapy until disease progression (PD). At the time of PD, patients will re-introduce XELOXIRI plus bev at the same doses and schedule previously tolerated, for a maximum of 12 cycles.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
91
CAP 1,600 mg/sq.m /day (p.o. day1-10) D1-10; Oxaliplatin (OX): 68 mg/sq.m (d.i.v.) D1; Irinotecan (IRI):135 mg/sq.m (d.i.v.) D1; BEV: 5mg/kg (d.i.v.) D1; Administered every 2 weeks.
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
RECRUITINGReintroduction Rate
The rate of patients who receive reintroduction therapy after the first progression.
Time frame: Up to 18 months
R0 rate
resection rate
Time frame: Up to 18 months
PFS
the time from randomization to the first documentation of objective disease progression or death due to any cause, whichever occurs first.
Time frame: Up to 18 months
OS
the time from randomization to the date of death due to any cause.
Time frame: Up to 18 months
PFS1
the time from randomization to the first documentation of objective disease progression or death due to any cause before second-line therapy, whichever occurs first.
Time frame: Up to 18 months
ORR1
percentage of patients, relative to the total of enrolled subjects, achieving a complete (CR) or partial (PR) response, according to RECIST 1.1 criteria, during the first-line induction and the maintenance phases of treatment.
Time frame: Every 8 weeks, up to 18 months after last patient last visit
PFS2
from the beginning of the second-line treatment to the documentation of objective disease progression or death due to any cause, whichever occurs first
Time frame: up to 18 months after last patient last visit
ORR2
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percentage of patients, relative to the total of enrolled subjects, achieving a complete (CR) or partial (PR) response, according to RECIST 1.1 criteria, during the second-line induction and the maintenance phases of treatment.
Time frame: Every 8 weeks, up to 18 months after last patient last visit