ctDNA-Guided Cetuximab or Bevacizumab Plus Trifluridine/Tipiracil in RAS/BRAF Wild-Type mCRC

Sponsor
Sun Yat-sen University
Study ID
NCT07012954
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Colorectal Cancer Metastatic

Eligibility Criteria

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

Interventions

  • Cetuximab (Erbitux, C225) — DRUG
    cetuximab 500 mg/m² repeated every two weeks.
  • trifluridine/tipiracil — DRUG
    Trifluridine/tipiracil 35 mg/m² (orally for 5 days, followed by 9 days off)
  • Bevacizumab ( Avastin) — DRUG
    bevacizumab 5 mg/kg

Study Details

The objective of this randomized controlled clinical trial is to evaluate the efficacy of ctDNA-guided rechallenge with cetuximab plus trifluridine/tipiracil compared with bevacizumab plus trifluridine/tipiracil in patients with treatment-refractory, RAS/BRAF wild-type metastatic colorectal cancer.

Key Dates

First listed
Jun 10, 2025
Start date
Jun 1, 2025
Status verified
Jun 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2030

Study Design

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

Arms

  • Experimental: cetuximab plus trifluridine/tipiracil
    Trifluridine/tipiracil 35 mg/m² (orally for 5 days, followed by 9 days off) plus cetuximab 500 mg/m² intravenous drip (IVD) once every two weeks.
  • Active Comparator: bevacizumab plus trifluridine/tipiracil
    Trifluridine/tipiracil 35 mg/m² (orally for 5 days, followed by 9 days off) plus bevacizumab 5 mg/kg administered by intravenous drip (IVD), repeated every two weeks.

Primary Outcome Measure

Objective Response Rate [ Time Frame: Assessed after every 4 cycles (each cycle is 14 days) from treatment initiation until radiographic disease progression, treatment discontinuation, or completion of the 5-year follow-up, whichever occurs first ]

Central Contacts

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