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Status unknownNCT05839470Updated Nov 15, 2023

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

A Phase 2 interventional study of cadonilimab and irinotecan in Colorectal Cancer, sponsored by Fujian Cancer Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-11-15.

Sponsored by Fujian Cancer Hospital · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

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.

Read the detailed description

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 in patients with metastatic microsatellite stable (MSS) colorectal cancer. The goal of this clinical trial is to evaluated the efficacy and safety.

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）

02

Conditions studied

  • Colorectal Cancer
03

In context

Colorectal Neoplasms

5,734 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.

This study's planned enrollment of 20 is below the median of 77 across 4,222 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Fujian Cancer Hospital is the lead sponsor of 162 studies on the registry; 92 are open to participants now.

Browse Fujian Cancer Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with metastatic pMMR or MSS colorectal adenocarcinoma. Note: MMR or MSI status will be performed locally by an immunohistochemistry (IHC) or PCR based test for eligibility.
  • Patients who are naïve to systemic treatment in metastatic setting.
  • Patients with previous neoadjuvant or adjuvant chemotherapy (that may have included oxaliplatin or investigational VEGF inhibitors) are eligible if the treatment was completed > 12 months before inclusion.
  • Patients with the presence of at least one lesion with measurable disease as per RECIST 1.1 guidelines. Lesions in previously irradiated areas should not be considered measurable unless they have clearly progressed since the radiotherapy.
  • Patients have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Exclusion criteria

Exclusion Criteria:

  • Patients with MSI-H colorectal adenocarcinoma as defined per local assessment using standard of care testing
  • Patients with metastatic disease amenable to be resected with potentially curative surgery
  • Patients who have received any systemic treatment for metastatic disease.
  • Patients with a history of prior treatment with anti-PD-1, anti-PD-L1, anti-PDL2, anti-CTLA-4 antibodies, other checkpoint inhibitors
  • Patients who had received radiation within 14 days prior to the first dose of study drug
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study 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）

    Drug: cadonilimab · Drug: irinotecan · Drug: Oxaliplatin · Drug: leucovorin or levoleucovorin · Drug: 5-FU

Interventions

  • Drugcadonilimab

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

  • Drugirinotecan

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

  • DrugOxaliplatin

    oxaliplatin 85 mg/m² iv continue for 2 hours,

  • Drugleucovorin or levoleucovorin

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

  • Drug5-FU

    5-FU 2400 mg/m² cont. inf. 46h

06

What researchers measure

Primary outcomes

  1. Overall Response Rate (ORR)

    RECIST 1.1

    Time frame: Up to two years

Secondary outcomes

  1. Progression free survival (PFS)

    RECIST 1.1

    Time frame: Up to two years

07

Study locations

1 of 1 sites recruiting
  • Fujian Cancer Hospital
    Fuzhou, Fujian, China
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2023; primary completion for Mar 2024, 3 months later.

Of 476 non-industry phase 2 interventional studies under Colorectal Neoplasms, half reached primary completion within 50 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 72. This study's planned 3 months is below that.

Counting every sponsor, half of 584 studies reached it within 47 months; a quarter within 30 and three quarters within 72.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 19, 2023
First posted
May 3, 2023
StartEst.
Nov 19, 2023
Primary completionEst.
Mar 1, 2024
CompletionEst.
Mar 1, 2025
Last update
Nov 15, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05839470
Lead sponsor
Fujian Cancer Hospital
Responsible party
Sponsor
First posted
May 3, 2023
Start date
Nov 19, 2023 (estimated)
Primary completion
Mar 1, 2024 (estimated)
Completion
Mar 1, 2025 (estimated)
Last update
Nov 15, 2023

Study contacts

Rongbo Lin
Contact
rongbo_lin@163.com
0591-83660063

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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