First-Line Treatment Induced With mFOLFOX6 and HLX04 Regimen, Following Combined With Serplulimab… (NCT06491355) | Clinical Trial Compass
Not Yet RecruitingPhase 2
First-Line Treatment Induced With mFOLFOX6 and HLX04 Regimen, Following Combined With Serplulimab in MSS Initially Unresectable Metastatic Colorectal Cancer
China72 participantsStarted 2024-07-01
Plain-language summary
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).
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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.
✓. MSS type or pMMR.
✓. Patients are required to have at least one measurable lesion (RECIST 1.1).
✓. ECOG physical strength status: 0-1 point.
✓. Expected survival of 12 weeks.
Exclusion criteria
✕. 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.
What they're measuring
1
Progression free survival（PFS）
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
✕. 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.
✕. Previous treatment with an oxaliplatin-based chemotherapy regimen.
✕. Symptomatic brain or meningeal metastases.
✕. Metastatic colorectal cancer with either MSI-H or dMMR.
✕. Severe infection (e. g. intravenous infusion of antibiotics, antifungals or antiviral drugs), or unexplained fever\> 38.5℃ during screening / first dose.