This is a prospective, multi-center, randomized controlled clinical intervention study, aiming to explore the effectiveness and safety of mfolfox6 and hlx04 regimens combined with slulimumab as first-line treatment for MSS-type initial unresectable metastatic colorectal cancer after induction therapy. This study plans to include a total of 72 patients with untreated MSS-type initial unresectable metastatic colorectal cancer.
This study randomly allocated groups through a randomization system, and entered the following treatment groups at a ratio of 1:1: (1) Experimental group: mfolfox6 and hlx04 regimen induction therapy followed by slulimab treatment (36 cases); (2) Control group Group: mfolfox6 and hlx04 regimen treatment (36 cases).
The patient volunteered to participate in the study, signed the informed consent form, and had good compliance.
Age: 18-75 years old (including 18 years old and 75 years old).
Body weight of 40kg.
Metastatic colorectal cancer confirmed by histology and / or cytology and initially unresectable.
Have received the following treatments within the first 4 weeks of treatment: tumor radiotherapy, surgery, chemotherapy, immune or molecular targeted therapy, and other clinical study drugs.
Active autoimmune diseases requiring systemic treatment (i. e., corticosteroids or immunosuppressive agents) have occurred in the past 2 years. Alternative therapies (such as thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) are not considered systemic treatment.
Diagnosis with immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first treatment. A physiological dose of corticosteroids may be approved after consultation with the investigator.
Previous small molecule targeted drug therapy, such as fuquintinib, etc.
Parallel
mfolfox6 and hlx04 regimen and Serplulimab
Drugmfolfox6 and hlx04 regimen induction therapy followed by combined treatment with slulimumab in the experimental arm. In the active comparator. only with mfolfox6 and hlx04 regimen treatment.
mfolfox6 and hlx04 regimen
DrugIn the active comparator. only with mfolfox6 and hlx04 regimen treatment.
Progression free survival（PFS）
The time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first.
objective response rate(ORR)
It refers to the proportion of patients whose tumors have shrunk to a certain amount and maintained for a certain period of time
disease control rate(DCR)
Refers to the proportion of patients with best overall assessment of complete response, partial response, or stable disease.
overall survival(OS)
Overall survival (os) is defined as the date from randomization to death from any cause.
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