Colorectal CancerPhase 2NCT05839470
Cadonilimab Plus FOLFOXIRI and Bevacizumab as First Line Therapy for Metastatic MSS Colorectal Cancer
A Phase 2 study testing cadonilimab, irinotecan and Oxaliplatin in people with Colorectal Cancer, run by Fujian Cancer Hospital at 1 site in China.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- cadonilimab, irinotecan and Oxaliplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 19 Nov 2023to 1 Mar 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian
Rongbo Lin, 0591-83660063, rongbo_lin@163.com
About this study
Official title: A Phase II, Prospective, Multicenter Study of Cadonilimab in Combination With FOLFOXIRI and Bevacizumab as First Line Therapy for Metastatic MSS Colorectal Cancer.
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）
- Conditions
- Colorectal Cancer
- Being tested
- cadonilimab, irinotecan, Oxaliplatin, leucovorin or levoleucovorin, 5-FU
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cadonilimabDrug
Cadonilimab (6mg/kg, iv, Q2W, Day1)
irinotecanDrug
irinotecan* 165 mg/m² iv continue for 1.5 hours, D1
OxaliplatinDrug
oxaliplatin 85 mg/m² iv continue for 2 hours,
leucovorin or levoleucovorinDrug
leucovorin 400 or levoleucovorin 200 mg/m² iv continue for 2 hours
5-FUDrug
5-FU 2400 mg/m² cont. inf. 46h
| Study group | Role | What they receive |
|---|---|---|
| Cadonilimab+ FOLFOXIRI+bevacizumab | Experimental | 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） Receives: Drug: cadonilimab; Drug: irinotecan; Drug: Oxaliplatin; Drug: leucovorin or levoleucovorin; Drug: 5-FU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
RECIST 1.1
Measured: Up to two years
Secondary outcomes (1)
Progression free survival (PFS)
RECIST 1.1
Measured: Up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start19 Nov 2023 (estimated)
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Fujian Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05839470
- Sponsor's protocol ID
- SYLT-026
- Status last verified
- Nov 2023
- First submitted
- 19 Apr 2023
- Last updated
- 15 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Prospective, Multicenter Study of Cadonilimab in Combination With FOLFOXIRI and Bevacizumab as First Line Therapy for Metastatic MSS Colorectal Cancer.
- ClinicalTrials.gov ID
- NCT05839470
- Acronym / sponsor ID
- SYLT-026
- Conditions
- Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 19 Nov 2023 (estimated)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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）
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cadonilimab+ FOLFOXIRI+bevacizumab | Experimental | Drug: cadonilimab, Drug: irinotecan, Drug: Oxaliplatin, Drug: leucovorin or levoleucovorin, Drug: 5-FUCadonilimab (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） |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cadonilimabCadonilimab (6mg/kg, iv, Q2W, Day1) | Drug | Cadonilimab+ FOLFOXIRI+bevacizumab |
| irinotecanirinotecan* 165 mg/m² iv continue for 1.5 hours, D1 | Drug | Cadonilimab+ FOLFOXIRI+bevacizumab |
| Oxaliplatinoxaliplatin 85 mg/m² iv continue for 2 hours, | Drug | Cadonilimab+ FOLFOXIRI+bevacizumab |
| leucovorin or levoleucovorinleucovorin 400 or levoleucovorin 200 mg/m² iv continue for 2 hours | Drug | Cadonilimab+ FOLFOXIRI+bevacizumab |
| 5-FU5-FU 2400 mg/m² cont. inf. 46h | Drug | Cadonilimab+ FOLFOXIRI+bevacizumab |
Primary outcome
Overall Response Rate (ORR)
Time frame: Up to two years
RECIST 1.1
1 secondary outcome
Progression free survival (PFS)
Time frame: Up to two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cadonilimab, irinotecan and Oxaliplatin in people with Colorectal Cancer, run by Fujian Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rongbo Lin (0591-83660063, rongbo_lin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) (time frame: Up to two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023; AzTrials last refreshed its copy on 7 Nov 2026.