Tislelizumab Plus Cetuximab and Irinotecan vs Third-line Standard-of-care in Refractory mCRC

Sponsor
Shanghai Zhongshan Hospital
Study ID
NCT05278351
Phase
PHASE2
Status
Unknown

Conditions

  • Colorectal Neoplasms Malignant

Eligibility Criteria

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

Interventions

Study Details

This is a multicenter, randomized, controlled, phase II study to evaluate the efficacy and safety of tislelizumab combined with cetuximab and irinotecan（group A） compared to third-line regimens selected by researchers（group B） in the treatment of Ras wild-type recurrent and refractory metastatic colorectal cancer. This study will include Ras wild-type colorectal cancer that failed at least second-line treatment inthe past, including chemotherapy (oxaliplatin, irinotecan, fluorouracil) with or without targeted drugs (cetuximab, bevacizumab). 87 patients will be randomly assigned to group A and group B according to 2:1. The enrollment time is expected to be 12 months and the follow-up is expected to be 24 months.

Key Dates

Start date
Jul 13, 2022
Status verified
Mar 2023
Primary completion
Apr 1, 2024
Completion
Dec 1, 2025

Study Design

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

Arms

  • Experimental: A
    Tislelizumab 200mg, D1, D15, intravenous drip, Q4W and Cetuximab 500mg/m2, D1, D15, intravenous drip, Q4W and Irinotecan 180mg/m2, D1, D15, intravenous drip, Q4W
  • Active Comparator: B
    Fruquinitinib 5mg QD D1-21, oral, Q4W or Regorafenib 160mg QD D1-21 oral, Q4W or Trifluridine Tipiracil Tablets 35mg/m2 BID D1-D5, D8-D12 oral, Q4W

Primary Outcome Measure

Progression free survival time (PFS) [ Time Frame: 24 months after the last subject participating in ]

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