Efficacy and Safety of Tunlametinib Combination Therapy in the Treatment of Second-line and Above Metastatic Colorectal Cancer

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSun Yat-sen University

About this trial

This study investigated the efficacy and safety of Tunlametinib Combination Therapy in the Treatment of Second-line and Above Metastatic Colorectal Cancer.

Eligibility criteria

Qualifiers

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).

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Arm1
  • Arm 2
  • Arm 3

Treatment groups

91 Participants
are divided into 3 treatment groups

Sponsors and collaborators