Cetuximab, Irinotecan, Toripalimab in RAS/BRAF Wild-type Ultraselected Right-sided Colorectal Cancer Study

Sponsor
Sun Yat-sen University
Study ID
NCT06547203
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Colorectal Cancer Metastatic

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Cetuximab — DRUG
    Cetuximab: 500 mg/m², intravenous infusion, once every 2 weeks
  • Toripalimab — DRUG
    Toripalimab: 3 mg/kg, intravenous infusion, once every 2 weeks.
  • Irinotecan — DRUG
    Irinotecan: 150 mg/m², intravenous infusion, once every 2 weeks.

Study Details

The objective of this clinical trial is to evaluate the efficacy and safety of cetuximab combined with PD-1 inhibitor and irinotecan in negative ultraselection RAS/BRAF wild-type refractory right-sided metastatic colorectal cancer.

Key Dates

Start date
Jul 18, 2024
Status verified
Aug 2024
Primary completion
Jul 30, 2026
Completion
Jul 30, 2029

Study Design

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

Arms

  • Experimental: Cetuimab plus toripalimab and irinotecan
    Single Arm study, with patients receiving: Cetuximab: 500 mg/m², intravenous infusion, once every 2 weeks. Toripalimab: 3 mg/kg, intravenous infusion, once every 2 weeks. Irinotecan: 150 mg/m², intravenous infusion, once every 2 weeks. Patients will continue treatment until any of the following conditions occur: the researcher determines there is no longer a clinical benefit, intolerable toxicity occurs, a new anti-tumor treatment is initiated, withdrawal of informed consent, loss to follow-up, death, or other conditions specified in the protocol requiring termination of treatment.

Primary Outcome Measure

Objective Response Rate [ Time Frame: Assessed after every 4 cycles (each cycle is 14 days) for up to 24 months ]

Central Contacts

Related Studies