c-CetuIRI Versus Ersecond-line Irinotecan s-IRI-CetuIRI

Sponsor
Fudan University
Study ID
NCT04833036
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Irinotecan — DRUG
    180 mg/m2, ivgtt d1，q2w
  • cetuximab — DRUG
    500 mg/m2, ivgtt d1，q2w

Study Details

The primary endpoint is to evaluate the progression-free survival (PFS).

Key Dates

Start date
Oct 1, 2019
Status verified
Apr 2021
Primary completion
Jan 31, 2022
Completion
Nov 30, 2022

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: c-CetuIRI
    Irinotecan combined with cetuximab
  • Experimental: s-IRI-CetuIRI
    single irinotecan first, then irinotecan plus cetuximab sequentially after PD

Primary Outcome Measure

PFS [ Time Frame: up to 8 weeks ]

Central Contacts

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