colorectal cancer
Conditions
Interventions
Case series:None
Sponsors
Peking Union Medical College Hospital, Chinese Academy of Medical Science
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Sign an informed consent form and voluntarily participate in this study (2) Age 18-80 years old (3) Pathologically confirmed metastatic colorectal adenocarcinoma; (4) The first or second generation sequencing of tumor tissue confirms the presence of BRAF V600E mutation; (5) Previously received targeted therapy with anti-EGFR monoclonal antibodies combined with BRAF inhibitors (such as Verafenib, Dalafenib, or Conefenib), and the optimal therapeutic effect reached complete or partial remission or disease stability lasting for = 4 months; (6) Disease progression during treatment with clinically or imaging confirmed anti-EGFR monoclonal antibodies combined with BRAF inhibitors; (7) After the progression of anti EGFR monoclonal antibody combined with BRAF inhibitor, the patient received = 1 line systemic therapy and progressed, and non MAPK signaling pathway blockade targeted therapy; (8) The time from the end of treatment with first-line or second-line anti-EGFR monoclonal antibodies combined with BRAF inhibitors to the start of challenge with EGFR/BRAF/MEK combined targeted therapy is = 4 months; (9) There are measurable lesions that meet the definition of RECIST 1.1 standard; (10) Researchers have determined that cetuximab combined with BRAF inhibitors ± MEK inhibitors can be accepted as a rechallenge for further treatment
Exclusion criteria
Exclusion criteria: (1) Previously, there were grade 3/4 adverse reactions or allergies to cetuximab during treatment with anti EGFR monoclonal antibodies combined with BRAF inhibitors; (2) A history of thromboembolism or cardiovascular events within = 3 months prior to the start of research treatment, including deep vein thrombosis, pulmonary embolism, cerebrovascular accidents, and acute myocardial ischemic events; (3) The cured basal cell or squamous cell skin cancer, superficial bladder cancer, prostatic intraepithelial tumor, and cervical carcinoma in situ had or were complicated with malignant tumors within 5 years before entering the study, but not included. (4) Pregnant or lactating women; (5) The researcher determined that other situations were not suitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival;Overall Survival;Disease Control Rate;Duration of Response; | — |
Countries
China
Contacts
Public ContactXicheng Wang
Peking Union Medical College Hospital, Chinese Academy of Medical Science
Outcome results
None listed