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.
The present study focuses on exploring the effectiveness and safety of cetuximab combined with a PD-1 inhibitor and irinotecan in treating refractory, right-sided metastatic colorectal cancer (mCRC) patients who are negative ultraselected for RAS/BRAF mutations. Colorectal cancer ranks among the most prevalent digestive malignancies globally, with right-sided mCRC generally exhibiting poorer outcomes than left-sided cases. Current treatment guidelines vary based on genetic mutations and tumor location, recommending cetuximab for left-sided RAS/BRAF wild-type mCRC and alternative therapies for right-sided or mutated cases. Despite limited clinical data on EGFR inhibitors for right-sided mCRC, retrospective analyses suggest varying efficacy outcomes. The study aims to address these gaps by investigating cetuximab and PD-1 inhibitor combination therapy in this specific patient population, potentially enhancing treatment options for refractory mCRC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
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.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGObjective Response Rate
The proportion of patients who have achieved partial response (PR) plus complete response (CR), as assessed by the investigator using RECIST v1.1 criteria
Time frame: Assessed after every 4 cycles (each cycle is 14 days) for up to 24 months
Disease Control Rate
The proportion of patients who have achieved complete response (CR), partial response (PR), or stable disease (SD) following treatment initiation.
Time frame: Assessed after every 4 cycles (each cycle is 14 days) for up to 24 months
Duration of Response
Length of time from the initial detection of a measurable response (complete response or partial response) to the treatment until the first documentation of disease progression or recurrence
Time frame: Assessed after every 4 cycles (each cycle is 14 days) for up to 24 months
Progression-Free Survival
The length of time from the start of treatment until the disease progresses or the patient dies from any cause, whichever occurs first.
Time frame: Assessed up to 24 months
Overall Survival
Defined as the time from the start of study treatment to death due to any cause
Time frame: Assessed throughout the study duration (5 years)
Adverse events (Treatment-related)
Assessment of adverse events and their severity according to NCI CTCAE version 5.0 criteria.
Time frame: Assessed throughout the study duration (5 years)
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