BRAF V600E-mutated colorectal cancer
Conditions
Interventions
Encorafenib,binimetinib,cetuximab
Sponsors
KAGAWA Yoshinori
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically diagnosed adenocarcinoma of the colon or rectum (excluding appendiceal cancer and anal canal cancer) 2) Patients with RAS wild-type and BRAF V600E mutation proved by tumor tissue 3) Patients who received postoperative adjuvant chemotherapy after pStage II/III radical resection and meet any of the following criteria a) Recurrence during adjuvant chemotherapy b) Recurrence within 6 months after postoperative adjuvant chemotherapy due to adverse events c) Recurrence within 6 months after scheduled adjuvant chemotherapy 4) No prior treatment with encorafenib, binimetinib, or cetuximab 5) Measurable lesions based on the RECIST v1.1 6) Performance Status (ECOG) 0-2 7) Age=>20 years 8) Patients who can take oral medication 9) Meet all of the following conditions a) Neutrophil count=>1,200/mm3 b) Hemoglobin=> 9.0 g/dL (No blood transfusion within 14 days prior to registration) c) Platelet count => 75,000/mm3 d) Total bilirubin = 50 mL/min 10) Patients are expected to survive for at least 12 weeks 11) With written informed consent
Exclusion criteria
Exclusion criteria: 1) Synchronous or metachronous active malignancies with a disease-free interval of 5 years or less 2) Symptomatic brain metastasis or meningitis 3) Women who are pregnant, breast feeding, or who wish to conceive. Men who wish to conceive 4) Unrecovered grade 2 or higher (CTCAE ver.5.0) AEs related to previous treatment (excluding anemia, alopecia, skin pigmentation, and oxaliplatin-induced peripheral neuropathy and proteinuria) 5) Patients with active infections (fever of 38 centigrade or higher) 6) History of myocardial infarction, severe/unstable angina, New York Heart Association (NYHA) Class III or IV symptomatic congestive heart failure within the past 6 months from the date of enrollment 7) Poorly controlled hypertension with a systolic blood pressure of 150 mmHg or diastolic blood pressure of 100 mmHg or higher, even with medication 8) Poorly controlled active hepatitis B with detectable HBV-DNA despite the administration of nucleic acid analogs, active hepatitis C with positive HCV-RNA, or known HIV infection 9) Ascites, pleural effusion or pericardial effusion requiring continuous drainage on the date of enrollment 10) Patients with a history of, or currently suffering from, retinal vein occlusion, or at risk for such occlusion 11) Patients with concomitant psychosis or psychiatric symptoms that make it difficult to participate in clinical research 12) Patient treated with any of the following within a certain period of time prior to the start of protocol treatment a) Extensive surgery within 4 weeks (excluding CV port placement) b) Stoma surgery within 2 weeks 13) Other cases in which physicians judges that the subject is inappropriate for this clinical research
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival,Progression free survival, Disease control rate, Duration of response, Time to treatment failure, Rate of adverse events | — |
Contacts
Public ContactYoshinori KAGAWA
Osaka International Cancer Institute
Outcome results
None listed