Cetuximab Plus Irinotecan in Patients With NeoRAS Wild-type Metastatic Colorectal Cancer In Third-line Therapy

Sponsor
Sun Yat-sen University
Study ID
NCT05962502
Phase
PHASE2
Status
Recruiting
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Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

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

Interventions

Study Details

This is a single-arm, open-label, phase II clinical trial. The goal of this study is to evaluate the efficacy and safety of cetuximab plus irinotecan in patients with NeoRAS wild-type primary left-sided mCRC in third-line therapy.

Key Dates

Start date
Aug 24, 2023
Status verified
Aug 2023
Primary completion
Mar 30, 2025
Completion
Dec 30, 2026

Study Design

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

Arms

  • Experimental: cetuximab plus irinotecan
    Cetuximab 500 mg/m2 iv drip 90 min d1, Irinotecan 180 mg/m2 iv drip d1 (For patients with UGT\*28 7/7 or UGT\*6 A/A or UGT\*28 6/7 plus UGT\*6 A/G, irinotecan 150 mg/m2 is used) The above regimen is repeated every 2 weeks

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: Up to 1 year ]

Central Contacts

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