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An open, multicenter phase II clinical study to evaluate safety and efficacy of HLX208 (BRAF V600E inhibitor) combined with cetuximab for metastatic colorectal cancer (mCRC) with BRAF V600E Mutation after first-line treatment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Never use other BRAF inhibitor therapy | Experimental | Never use other BRAF inhibitor therapy |
|
| PD after other BRAF inhibitor therapy N=5~40 | Experimental | PD after other BRAF inhibitor therapy |
|
| SD but intolerant after other BRAF inhibitor therapy | Experimental | SD but intolerant after other BRAF inhibitor therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HLX208 | Drug | HLX208 450mg bid po OR 600mg bid po OR 900mg bid po |
|
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective response rate(assessed by independent radiological review committee (IRRC) based on the RECIST Version 1.1) | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | Progression-free survival (PFS) (assessed by IRRC and the investigator as per RECIST v1.1 ) | from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years] |
| OS |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Affiliated Oncology Hospital | Shanghai | China |
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|
| Cetuximab Injection [Erbitux] | Drug | Cetuximab 500 mg/m2 IV Q2W |
|
Overall survival
| from the date of first dose until the date of death from any causeļ¼assessed up to 2 years |
| ID | Term |
|---|---|
| C000726503 | CCT239065 |
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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