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

NCT05839470 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-11-15

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

cadonilimab

Cadonilimab (6mg/kg, iv, Q2W, Day1)

DRUG

irinotecan

irinotecan\* 165 mg/m² iv continue for 1.5 hours, D1

DRUG

Oxaliplatin

oxaliplatin 85 mg/m² iv continue for 2 hours,

DRUG

leucovorin or levoleucovorin

leucovorin 400 or levoleucovorin 200 mg/m² iv continue for 2 hours

DRUG

5-FU

5-FU 2400 mg/m² cont. inf. 46h

Sponsors & Collaborators

  • Fujian Cancer Hospital

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-19
Primary Completion
2024-03-01
Completion
2025-03-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05839470 on ClinicalTrials.gov