This is a prospective, multicenter, randomized controlled, phase II study. It is expected to enroll 229 patients and aims to evaluate the efficacy and safety of FOLFOX8 versus mFOLFOX6 combined with bevacizumab or cetuximab as first-line treatment for unresectable metastatic colorectal cancer. The primary objective is to assess progression-free survival (PFS) of the patients. Secondary objectives include assessment of objective response rate (ORR), overall survival (OS), safety, and other outcomes.
Age ≥ 18 years, male or female.
ECOG performance status 0-2.
Histologically or cytologically confirmed unresectable metastatic colorectal cancer with no prior treatment for unresectable or metastatic disease.
Adequate organ function: Hb ≥ 70 g/L; WBC ≥ 3.0×10⁹/L; NEUT ≥ 1.5×10⁹/L; PLT ≥ 75×10⁹/L; AST and ALT ≤ 3× ULN; sCr ≤ 2× ULN; TBIL ≤ 2× ULN.
Known allergy to the study drug(s) and/or their excipients.
Contraindications to chemotherapy.
Patients with MSI-H or dMMR colorectal cancer.
Patients with BRAF mutation.
Parallel
Oxaliplatin
Drug85 mg/m² intravenously over 2 hours on Day 1, every 2 weeks for up to 12 cycles. For patients without disease progression after 12 cycles, oxaliplatin is discontinued and not used in maintenance.
5-Fluorouracil
Drug400 mg/m² intravenous bolus on Day 1, followed by 2400 mg/m² administered as a continuous intravenous infusion over 46-48 hours. Cycle repeats every 2 weeks for up to 12 cycles. Patients without disease progression then enter maintenance with the same 5-FU regimen every 2 weeks until disease progression or unacceptable toxicity.
Levofolinic Acid For Injection
Drug200 mg/m² mixed with 5-FU 2400 mg/m² as a continuous intravenous infusion over 46-48 hours on Day 1 (concurrent infusion). Cycle repeats every 2 weeks for up to 12 cycles. Patients without disease progression then enter maintenance with the same mixture every 2 weeks until disease progression or unacceptable toxicity.
Calcium Folinate
Drug400 mg/m² intravenously over 2 hours on Day 1, administered sequentially before 5-FU. Cycle repeats every 2 weeks for up to 12 cycles. Patients without disease progression then enter maintenance with the same dose and schedule of calcium folinate (without oxaliplatin) every 2 weeks until disease progression or unacceptable toxicity.
Bevacizumab
Drug5 mg/kg intravenously on Day 1 every 2 weeks, starting from Cycle 2 (after genetic testing results are available). Continue through induction and maintenance until disease progression or unacceptable toxicity.
Cetuximab (EGFR inhibitor)
Drug500 mg/m² intravenously over more than 2 hours on Day 1 every 2 weeks, starting from Cycle 2 (after genetic testing results are available). Continue through induction and maintenance until disease progression or unacceptable toxicity.
Progression-Free Survival（PFS）
Defined as the time from randomization to disease progression or death from any cause.
Objective Response Rate（ORR）
Defined as the proportion of subjects achieving complete response or partial response evaluated by investigator based on RECIST 1.1
Overall Survival (OS)
Defined as the time from randomization to death from any cause.
Impact of Treatment Regimen on Infusion Time
Total time required for intravenous infusion of leucovorin/Levofolinic Acid For Injection and 5-FU per cycle.
Incidence of Adverse Events（AEs）
The incidence, severity, and causality of treatment-emergent adverse events (TEAEs) will be assessed according to CTCAE v5.0.
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