This is a prospective randomized controlled Phase Ⅱ/Ⅲ Clinical study to evaluate the clinical efficacy and safety of Envafolimab combining with Cetuximab -β and mFOLFOX6 in Patients With MSS, RAS/BRAF Wild-Type Metastatic Colorectal Cancer (mCRC)
Patients diagnosed with unresectable, microsatellite - stable (MSS), RAS/BRAF wild - type metastatic colorectal adenocarcinoma who have not received prior systemic anti-neoplastic therapy for metastatic or recurrent lesions will be included in this study. In the Phase II study, approximately 186 patients will be enrolled, with 93 assigned to the experimental group and 93 to the control group. In the Phase III study, around 404 patients will be recruited, with 202 allocated to the experimental group and 202 to the control group. Eligible patients will undergo a screening period of up to 28 days, followed by a treatment period consisting of 2 - week cycles for a maximum duration of 2 years. Subsequently, a follow - up period will be implemented, which includes a safety follow - up and survival follow - ups conducted every 12 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
590
500 mg/m², initial intravenous infusion (IV)\>120 min, subsequent IV \>60 min , D1,every 2 weeks
a single fixed dose of 200 mg, subcutaneous injection(SC), every 2 weeks (Day 1 of each cycle \[D1\])
Oxaliplatin 85 mg/m² , IV, over 120 min, Day 1; Leucovorin 400 mg/m² (or Calcium Folinate 200 mg/m²), IV, over 120 min, D1; 5-FU 400 mg/m² , bolus injection, followed by 1200 mg/(m²·d) continuous IV for 2 days (total dose 2400 mg/m² over 46 - 48 hours)
Medical Oncology,Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Progressin Free Survival,PFS
Progression-free survival based on RECIST v1.1
Time frame: Time Frame: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 3 years
OS,Overall survival
Time frame: from the date of first dose unitl the date of death from any cause,assessed up to 3 years
ORR, Objective response
Objective response rate based on RECIST v1.1
Time frame: up to 3 years
DCR, Disease control rate
the proportion of patients with the best overall response of CR, PR, or stable disease (SD)
Time frame: up to 1 year
NED Rate, No Evidence of Disease Rate
The proportion of participants with no evidence of disease after treatment, as determined by current assessments (pathological, imaging, and molecular biology). NED includes complete response (CR), R0 resection, or other local treatments, such as radiofrequency, microwave, or cryoablation (which can be combined with surgery), that eliminate the tumor.
Time frame: up to 3 years
Safety(Adverse Event (AE) Incidence)
Adverse Event (AE) Incidence
Time frame: up to 3 years
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