This study investigated the efficacy and safety of Tunlametinib Combination Therapy in the Treatment of Second-line and Above Metastatic Colorectal Cancer.
Age ≥ 18 years of age, both genders.
ECOG, 0-1.
Patients with metastatic colorectal cancer confirmed by histology or cytology
Previous genetic test results can determine the gene status (mutation or wild type) of the RAS/RAF/MEK/ERK pathway (MAPK pathway), and the results of genetic testing or immunohistochemical testing can confirm whether it is MSS/pMMR or MSI-H/dMMR (if MSI-H/dMMR has been treated with PD-1 antibody, only the A cohort (MEK inhibitor + EGFR monoclonal antibody cohort) can be screened; if MSI-H/dMMR has not been treated with PD-1 antibody, the B cohort (MEK inhibitor + EGFR monoclonal antibody + PD-1 monoclonal antibody cohort) can be screened; if BRAF V600E mutation is present, the B cohort or C cohort (MEK inhibitor + EGFR monoclonal antibody / BRAF inhibitor + PD-1 monoclonal antibody cohort) can be screened).
Researchers must consider contraindications when selecting treatment drugs, such as allergies to any drug component.
subjects who have previously used the cohort's treatment drugs (EGFRi, MEKi, BRAFi, immunotherapy) are excluded from screening.
Within 4 weeks before the first use of the drug, underwent major surgery (excluding biopsies and minor outpatient surgeries, such as the placement of vascular access) or experienced serious trauma;
There is the presence of clinically symptomatic third space effusion (such as large pleural effusion or ascites) that cannot be controlled through drainage or other methods;
Parallel
Arm1
DrugTunlametinib + Cetuximab β Injection
Arm 2
DrugTunlametinib + Cetuximab β+Tislelizumab
Arm 3
DrugTunlametinib + BRAF inhibitor + Tislelizumab
Objective Response Rate (ORR)
Defined as the percentage of subjects achieving complete response (CR) or partial response (PR) as assessed by RECIST 1.1.
Progression Free Survival (PFS)
Defined as the time from randomization to the date of first documentation of from date of randomization until the date of first documented progression or date of death from any cause, whichever came first.
Disease Control Rate (DCR)
DCR was defined as the proportion of CR+PR+SD subjects to total subjects
Duration of Response (DoR)
DoR was defined as the time from when response (CR or PR) was first documented to first documented disease progression or death.
Overall Survival (OS)
From date of randomization until the date of death from any cause
Mechanism Exploration
Based on multi-omics(genome, transcriptomes, proteome ), explore the mechanisms of drug resistance in different cohorts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
