Dual EGFR/HER2 Blockade Combined With Irinotecan for the Treatment of HER2-Positive Metastatic Colorectal Cancer

Sponsor
Sun Yat-sen University
Study ID
NCT07059338
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Colorectal Cancer (CRC)
  • HER2 Positive

Eligibility Criteria

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

Interventions

Study Details

In colorectal cancer (CRC), HER2 has emerged as a critically targeted biomarker in recent years. Although multiple clinical trials have demonstrated the potential of HER2-targeted therapies in HER2-positive (overexpressed/amplified) metastatic CRC (mCRC), the duration of treatment response remains short with rapid disease progression. This underscores the urgent need to develop novel therapeutic strategies for HER2-positive mCRC. The EGFR pathway is constitutively activated in CRC and mediates resistance to HER2-targeted therapies through the formation of EGFR-HER2 heterodimers. Notably, EGFR-targeting antibodies combined with irinotecan can reverse irinotecan chemoresistance. Building upon these mechanisms, this study proposes to evaluate the combination of trastuzumab (anti-HER2), cetuximab beta (anti-EGFR), and irinotecan in chemotherapy-refractory HER2-positive mCRC.

Key Dates

Start date
Jul 11, 2025
Status verified
Jul 2025
Primary completion
Dec 30, 2027
Completion
Dec 30, 2028

Study Design

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

Arms

  • Experimental: Trastuzumab +Cetuximab β+Irinotecan
    Treatment regimen: All agents will be administered via intravenous infusion, consisting of trastuzumab (4 mg/kg every 2 weeks), cetuximab beta (500 mg/m² every 2 weeks) in combination with irinotecan (180 mg/m² every 2 weeks). Comprehensive radiological and laboratory assessments will be conducted after every 4 treatment cycles (8 weeks).

Primary Outcome Measure

6-month progression-free-survival rates [ Time Frame: 2 years ]

Central Contacts

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