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Targeted agents plus immunotherapy for BRAF mutant patients. In China.

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Criterios de inclusión

Criterios de inclusión:

Male or female ≥ 18 years of age
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
Participants must have histologically or cytologically confirmed diagnosis of adenocarcinoma of the colon or rectum, with clinical confirmation of unresectable and/or metastatic disease that is measurable according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria
Presence of BRAF V600E in tumor tissue determined by local assay at any time prior to screening and confirmed by central laboratory. And confirmation of MSS or pMMR status from immunohistochemistry or PCR or NGS;
Prior treatment with at least one systemic treatment (chemotherapy or target therapy) for mCRC, and prior treatment did not include cetuximab

Adequate organ and marrow function:

①Hemoglobin (Hb) ≥ 90 g/L；Platelets (PLT) ≥ 75 x 10^9/L；Neutrophil ≥1.5 x 10^9/L
②Total bilirubin ≤ 1.5 x upper limit of normal (ULN)；Aspartate aminotransferase (AST) ≤3 x ULN ；Alanine aminotransferase (ALT) ≤3 x ULN
③Serum creatinine ≤ 1.5 x ULN, or calculated creatinine clearance (determined as per Cockcroft-Gault) ≥ 50 mL/min at screening
④INR, APTT, and PT≤ 1.5 x ULN
⑤Serum albumin≥ 28 g/L
⑥ECG showed no evident abnormality
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Criterios de exclusión

Criterios de exclusión:

Known hypersensitivity or contraindication to any component of cetuximab or PD-1 monoclonal antibody or macromolecular protein reagent.
A history of other malignancies with a disease-free survival of less than 5 years, with the following exceptions: adequately treated basal or squamous cell skin cancer, carcinoma in-situ of the cervix, and gastrointestinal tumors treated curatively with endoscopic mucosectomy;
Any active autoimmune disease or a history of autoimmune disease
Use of immunosuppressive medications or glucocorticoid therapy ≤2 weeks prior to entry
Uncontrolled active infection requiring antibiotics
Known history of HIV infection or active hepatitis

Severe complications, including any of the following:

①Massive gastrointestinal bleeding, perforation, or gastrointestinal obstruction
②Symptomatic heart disease
③Uncontrolled diabetes and hypertension
④Uncontrolled diarrhea
Women who are pregnant or lactating and people who do not agree to avoid pregnancy
Patients with serious psychiatric that may interfere treatment.
Other conditions which are inappropriate to participate in the study confirmed by investigators.