Chemotherapy Plus Bevacizumab and Anti-PD-1 Followed by Induction Therapy of Chemotherapy Plus Bevacizumab

Sponsor
Zhangfa Song
Study ID
NCT06415851
Phase
PHASE2
Status
Unknown

Conditions

  • MSS
  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • mFOLFOX6 regimen + bevacizumab + PD-1 monoclonal antibody — DRUG
    This study is a single-arm intervention study. All subjects in this study will be treated with this study protocol, that is, after mFOLFOX6 protocol and bevacizumab induction therapy, combined with slulimumab treatment.

Study Details

Fluorouracil and oxaliplatin-based combined with molecular targeted drugs are still the main treatment strategies for patients with advanced metastatic colorectal cancer (mCRC). Multiple studies have confirmed that anti-PD-1 combined chemotherapy regimens can bring better survival benefits to patients with advanced mCRC. Slulimab is a humanized IgG4 monoclonal antibody with clear anti-tumor efficacy and easy management of adverse reactions. Therefore, the main purpose of this study is to explore the effectiveness of chemotherapy and bevacizumab induction therapy combined with PD-1 monoclonal antibody in the first-line treatment of MSS-type initial unresectable mCRC.

Key Dates

First listed
May 16, 2024
Start date
Jun 1, 2024
Status verified
May 2024
Primary completion
May 30, 2025
Completion
May 30, 2026

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: mFOLFOX6 regimen + bevacizumab + PD-1 monoclonal antibody
    Induction therapy: mFOLFOX6 regimen + bevacizumab. mFOLFOX6 regimen: Oxaliplatin 85 mg/m2 ; LV 400 mg/m2; 5-FU 400 mg/m2, Intravenous bolus injection, day 1, then maintain 1200mg/(m2∙d) × 2d continuous intravenous infusion (total volume 2400mg/m2, infusion 46-48h), q2w; Bevacizumab: 5mg/kg; lasting 2 cycles. Combination therapy: mFOLFOX6 regimen + bevacizumab + PD-1 monoclonal antibody. mFOLFOX6 regimen: Oxaliplatin 85 mg/m2 intravenously infused for 90-120 minutes on day 1; LV 400 mg/m2 intravenous infusion for 2 hours, combined with oxaliplatin injection time on day 1; 5-FU 400 mg/m2, Intravenous bolus injection, day 1, then maintain 1200mg/(m2∙d) × 2d continuous intravenous infusion (total volume 2400mg/m2, infusion 46-48h), q2w; bevacizumab: 5mg/kg, intravenously Infusion, day 1, q2w; Slulimab: 200 mg, intravenous infusion, day 1, q2w. Every 2 weeks is a cycle.

Primary Outcome Measure

progression free survival(PFS) [ Time Frame: 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 ]

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