ICE Study: Combination of Irinotecan Plus Cetuximab and Envafolimab as a Rechallenge Regimen in mCRC

Sponsor
Beijing Hospital
Study ID
NCT06321081
Phase
PHASE2
Status
Recruiting
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Conditions

  • MSS
  • Metastatic Colorectal Cancer
  • RAS Mutation

Eligibility Criteria

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

Interventions

Study Details

This is a non-profit phase II, open, clinical study of the combination of irinotecan plus cetuximab and envafolimab as a rechallenge regimen, in pre-treated RAS/BRAF wild type metastatic colorectal cancer patients (according to liquid biopsy at baseline). Patients have been treated in front lines with irinotecan and cetuximab and had a clinical benefit (complete or partial response) from both of them, no matter whether they had treated by any PD-1 inhibitor before.

Key Dates

Start date
Mar 1, 2024
Status verified
Mar 2024
Primary completion
Feb 14, 2026
Completion
Aug 14, 2026

Study Design

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

Arms

  • Experimental: ICE treatment group
    any RAS wild type mCRC patients who had got benefits from cetuximab or irinotecan will be treated with ICE regimen (Irinotecan 150mg/m2,Q2W, cetuximab 500mg/m2, Q2W, envafolimab 200mg, Q2w)

Primary Outcome Measure

progression free survival [ Time Frame: from screening up to 36 months (from the start of therapy until disease progression or death due to any cause ]

Central Contacts

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