Metastatic colorectal cancer
Conditions
Interventions
Observation group:None
Sponsors
The Sixth Affiliated Hospital , Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.The patient consents and signs the informed consent form in written form, agrees to have his/her data recorded and collected in anonymized form for the non-interventional study. 2.The patient has the full capacity for civil conduct and is aged >= 18 years old (without upper age limit). 3.The patient with BRAF V600E-mutant metastatic colorectal cancer has previously experienced at least first line systemic therapy. 4.The patient with mCRC has previously experienced the treatment with the protocol of Encorafenib in combination of Cetuximab (retrospective part). 5.The patient is eligible for the treatment with the protocol of Encorafenib in combination of Cetuximab and is expected to be treated with EC (prospective part).
Exclusion criteria
Exclusion criteria: 1.The patient has participated in an interventional clinical study during EC treatment in the retrospective part; he/she is currently participating in or planning to participate in an interventional clinical study in the prospective study. 2.The patient has other malignant tumor or has had other malignant tumor, except for basal cell carcinoma of the skin (BCC) and squamous cell carcinoma (SCC). 3.According to the investigator’s judgment, the patient is unsuitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The lines of EC-containing therapy protocol, therapy type , treatment sequence of EC-containing protocol;Duration of EC-containing therapy protocol, dosage adjustment, treatment protocol for each cycle;The distribution of treatment, dose interruption and administration termination, and reason for treatment discontinuation or treatment protocol change; | — |
Secondary
| Measure | Time frame |
|---|---|
| The clinical characteristics at baseline and demographics will be analyzed as secondary endpoints;PFS, PFS rates of 3 months and 6 months, OS, OS rates of 6 months and 1 year, ORR, and DoR;Incidence of AEs,abnormal laboratory results with clinical significance,clinically significant abnormal physical examinations,AEs lead to dose interruption,dose adjustment, treatment discontinuation;quality of life;Time and testing procedure for BRAF mutation testing; | — |
Countries
China
Contacts
Public ContactYanhong Deng
The Sixth Affiliated Hospital , Sun Yat-sen University
Outcome results
None listed