A Clinical Study on the Treatment of Metastatic Colorectal Cancer at the Second-line or Beyond.

Sponsor
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Study ID
NCT07395063
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Metastatic Colorectal Cancer (CRC)

Eligibility Criteria

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

Interventions

  • Irinotecan liposome combined with capecitabine, bevacizumab and camrelizumab — DRUG
    Zeirinotecan liposome: 60mg/m2, intravenous drip, completed within 90 minutes (±5 minutes). On the first day, administer once every 3 weeks. Capecitabine: 800mg/m ² orally, twice daily from day 1 to day 14, repeated every 3 weeks. Bevacizumab: 7.5mg/kg, intravenous infusion, day 1, once every 3 weeks; Camrelizumab: 200mg, intravenous infusion, on the first day, once every 3 weeks

Study Details

A single-arm, open-label clinical study of irinotecan liposome combined with capecitabine, bevacizumab and camrelizumab as second-line or above treatment for patients with metastatic colorectal cancer, aiming to evaluate the efficacy and safety of irinotecan liposome combined with capecitabine, bevacizumab and camrelizumab as second-line or above treatment for patients with metastatic colorectal cancer The medication regimen is irinotecan liposome (II) + capecitabine + bevacizumab + camrelizumab until disease progression or intolerable toxicity.

Key Dates

Start date
Feb 1, 2026
Status verified
Feb 2026
Primary completion
Feb 1, 2029
Completion
Feb 1, 2029

Study Design

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

Arms

  • Experimental: Irinotecan liposome combined with capecitabine, bevacizumab and camrelizumab
    Zeirinotecan liposome: 60mg/m2, intravenous drip, completed within 90 minutes (±5 minutes). On the first day, administer once every 3 weeks. Capecitabine: 800mg/m ² orally, twice daily from day 1 to day 14, repeated every 3 weeks. Bevacizumab: 7.5mg/kg, intravenous infusion, day 1, once every 3 weeks; Camrelizumab: 200mg, intravenous infusion, on the first day, once every 3 weeks

Primary Outcome Measure

Progression-free survival (PFS） [ Time Frame: through study completion,about 3 years ]

Central Contacts

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