NCT04160416

mXELOXIRI Combined With Molecular Targeted Drug in mCRC

mXELOXIRI Combined With Molecular Targeted Drug as First-line Therapy in Patients With Initially Unresectable Metastatic Colorectal Cancer: A Phase II, Single-arm, Prospective Clinical Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: First Affiliated Hospital of Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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)

Detailed description

It is an investigator-initiated, single institution, prospective, single-arm clinical study to evaluate the efficacy and safety of modified XELOXIRI combined with molecular targeted drug as first-line therapy in patients with unresectable mCRC. Eligible patients will receive 8 cycles of mXELOXIRI with cetuximab or bevacizumab and then the maintenance therapy until disease progression (PD) or unacceptable toxicity, whichever occurs first. Study evaluation time is defined as up to 16 weeks after the first dosing of the last patient.

Conditions

• Unresectable Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Capecitabine-Oxaliplatin-Irinotecan Combination	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.

Timeline

• Start date: 2019-07-01
• Primary completion: 2020-11-01
• Completion: 2022-01-01
• First posted: 2019-11-13
• Last updated: 2019-11-19

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study