Clinical Study of Second-line Treatment in Advanced Colorectal Cancer With Chemotherapy With Bevacizumab or Cetuximab

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study ID
NCT06540326
Phase
PHASE2
Status
Recruiting
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Conditions

  • Colorectal Cancer Metastatic

Eligibility Criteria

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

Interventions

  • irinotecan liposome (II) — DRUG
    irinotecan liposome (II) is a powerful chemotherapeutic agents, in the combination with fluorouracil，and bevacizumab or cetuximab
  • fluorouracil — DRUG
    fluorouracil is a powerful chemotherapeutic agents, in the combination with irinotecan liposome (II)，and bevacizumab or cetuximab
  • cetuximab — DRUG
    cetuximab is a powerful targeted agents, in the combination with irinotecan liposome (II)，and fluorouracil
  • bevacizumab — DRUG
    bevacizumab is a powerful targeted agents, in the combination with irinotecan liposome (II)，and fluorouracil
  • Capecitabine — DRUG
    Capecitabine is a powerful chemotherapeutic agent, in the combination with bevacizumab or cetuximab

Study Details

Guidelines recommend FOLFIRI in combination with bevacizumab or cetuximab as a treatment option for advanced second-line colorectal cancer, and this study explores the efficacy and safety of a clinical study of liposomal irinotecan (II), fluorouracil, in combination with bevacizumab or cetuximab for the second-line treatment of patients with advanced colorectal cancer.

Key Dates

Start date
Nov 12, 2024
Status verified
Jul 2025
Primary completion
Apr 15, 2026
Completion
Oct 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: irinotecan liposome (II), fluorouracil in combination with bevacizumab
    Experimental: irinotecan liposome (II), fluorouracil in combination with bevacizumab Induction therapy: irinotecan liposome (II), fluorouracil in combination with bevacizumab Maintenance therapy: bevacizumab with irinotecan liposome (II) or Capecitabine
  • Experimental: irinotecan liposome (II), fluorouracil in combination with cetuximab
    Experimental: irinotecan liposome (II), fluorouracil in combination with cetuximab Induction therapy: irinotecan liposome (II), fluorouracil in combination with bevacizumab Maintenance therapy: cetuximab with irinotecan liposome (II) or Capecitabine

Primary Outcome Measure

Objective Response Rate [ Time Frame: through study completion, an average of 1 year. ]

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