Efficacy and Safety of SBRT Followed by Tislelizumab Plus Cetuximab and Irinotecan in Patients With Previously Treated RAS Wild-type Advanced Refractory Colorectal Cancer

Sponsor
Fujian Cancer Hospital
Study ID
NCT05799443
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Tislelizumab — DRUG
    Tislelizumab will be administered on day 1 of each cycle at 200mg once every 14 days.
  • Irinotecan Hydrochloride — DRUG
    Irinotecan will be administered on day 1 of each cycle at 180 mg/m2 once every 14 days.
  • cetuximab — DRUG
    cetuximab will be administered on day 1 of each cycle at 500 mg/m2 once every 14 days.
  • SBRT — RADIATION
    8-10Gy×5F，QOD

Study Details

To evaluate the efficacy and safety of SBRT followed by tislelizumab plus cetuximab and irinotecan in patients with previously treated RAS wild-type advanced refractory colorectal cancer

Key Dates

Start date
Apr 5, 2023
Status verified
Mar 2023
Primary completion
Apr 5, 2024
Completion
Apr 5, 2025

Study Design

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

Arms

  • Experimental: SBRT followed by tislelizumab plus cetuximab and irinotecan

Primary Outcome Measure

Objective response rate(ORR) [ Time Frame: From enrollment to 12 month ]

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