Non-randomised, Multicentre, Prospective, Single-arm, Phase II Study of the Efficacy and Toxicity of a Combination of FOLFOX With Dabrafenib and Cetuximab/Panitumumab in the First Line of Therapy of Patients With Metastatic BRAF V600E- Mutated MSS Colorectal Cancer
The purpose of this study is to evaluate the efficacy and toxicity of FOLFOX regimen with dabrafenib and cetuximab/panitumumab in the first line of therapy for the potential treatment of colorectal cancer that: has a metastatic, inoperable; has a mutation in the BRAF gene and MSS. Participants in this study will receive one of the following study treatments: These participants will receive FOLFOX regimen with dabrafenib and cetuximab or panitumumab in the first line of therapy This study is currently enrolling participants who will receive either FOLFOX regimen with dabrafenib and cetuximab or panitumumab in the first line of therapy. The study team will monitor how each participant responds to the study treatment for up to about 3 years.
• Histologically confirmed colorectal adenocarcinoma that contains MSS and BRAF V600E mutation
• Metastatic inoperable colorectal cancer
• Adequate function of hematopoiesis and basic indicators of internal organs
• Has measurable or evaluable disease according to Response Evaluation Criteria In Solid Tumors (RECIST v1.1).
• Lacking antitumor systemic treatment for colorectal cancer.
• Patients with progression after adjuvant chemotherapy may be included if progression is recorded no earlier than 12 months after the last course of chemotherapy.
• The primary tumor is removed or asymptomatic.
• Absence of grade 2 or higher neuropathy.
• Absence of tumor MSI or dMMR.
• ECOG PS 0-2