Cadonilimab Plus FOLFOXIRI and Bevacizumab as First Line Therapy for Metastatic MSS Colorectal Cancer

Sponsor
Fujian Cancer Hospital
Study ID
NCT05839470
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • cadonilimab — DRUG
    Cadonilimab (6mg/kg, iv, Q2W, Day1)
  • irinotecan — DRUG
    irinotecan\* 165 mg/m² iv continue for 1.5 hours, D1
  • Oxaliplatin — DRUG
    oxaliplatin 85 mg/m² iv continue for 2 hours,
  • leucovorin or levoleucovorin — DRUG
    leucovorin 400 or levoleucovorin 200 mg/m² iv continue for 2 hours
  • 5-FU — DRUG
    5-FU 2400 mg/m² cont. inf. 46h

Study Details

Cadonilimab is a first-in-class bispecific, humanized IgG1 antibody targeting PD-1 and CTLA-4, which has the potential to boost immune surveillance in tumors. This was a phase II study of cadonilimab in combination with bevacizumab and FOLFOXIRI as first line therapy for metastatic microsatellite stable (MSS) colorectal cancer. The goal of this clinical trial is to evaluated the efficacy and safety.

Key Dates

Start date
Nov 19, 2023
Status verified
Nov 2023
Primary completion
Mar 1, 2024
Completion
Mar 1, 2025

Study Design

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

Arms

  • Experimental: Cadonilimab+ FOLFOXIRI+bevacizumab
    Cadonilimab (6mg/kg, iv, Q2W, Day1)+irinotecan\* 165 mg/m² iv continue for 1.5 hours, D1; oxaliplatin 85 mg/m² iv continue for 2 hours, D1; leucovorin 400 or levoleucovorin 200 mg/m² iv continue for 2 hours, D1; 5-FU 2400 mg/m² cont. inf. 48h; repeat every 2 weeks (Q2W) + bevacizumab （5mg/kg，d 1）

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: Up to two years ]

Central Contacts

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