mXELOXIRI Combined With Molecular Targeted Drug in mCRC

Sponsor
First Affiliated Hospital of Zhejiang University
Study ID
NCT04160416
Phase
PHASE2
Status
Unknown

Conditions

  • Unresectable Metastatic Colorectal Cancer

Eligibility Criteria

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

Interventions

  • Capecitabine-Oxaliplatin-Irinotecan Combination — DRUG
    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; CET: 500 mg/sq.m (d.i.v.) D1; Administered every 2 weeks.

Study Details

The objective is to evaluate the efficacy and safety of modified XELOXIRI combined with molecular targeted drug as first-line therapy in patients with metastatic colorectal cancer (mCRC)

Key Dates

Start date
Jul 1, 2019
Status verified
Nov 2019
Primary completion
Nov 1, 2020
Completion
Jan 1, 2022

Study Design

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

Arms

  • Experimental: mXELOXIRI
    Induction therapy is followed by the maintenance therapy. Induction treatment: XELOXIRI+CET/BEV Administered for 6 cycles (a maximum of 8 cycles).Bevacizumab (BEV): 5mg/kg (d.i.v.); Cetuximab 500mg/sq.m (d.i.v.)；Oxaliplatin (OX): 68 mg/sq.m (d.i.v.) Irinotecan (IRI):135 mg/sq.m (d.i.v.) CAP 1,600 mg/sq.m /day (p.o. day1-10) Administered every 2 weeks. Maintenance treatment: CAP+CET/BEV. The following CAP+BEV/CET therapy will be repeated in 2-week cycles.

Primary Outcome Measure

ORR [ Time Frame: Up to 36 months ]

Central Contacts

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