Combination therapy for metastatic colorectal cancer using cadonilimab, FOLFOXIRI, and bevacizumab
A Phase II, Prospective, Multicenter Study of Cadonilimab in Combination With FOLFOXIRI and Bevacizumab as First Line Therapy for Metastatic MSS Colorectal Cancer.
This study is testing a new combination of treatments for people with advanced colorectal cancer to see if it can improve their health and response to therapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Fujian Cancer Hospital Government |
| Drugs / interventions | chemotherapy, radiation, Cadonilimab, bevacizumab |
| Locations | 1 site (Fuzhou, Fujian) |
| Trial ID | NCT05839470 on ClinicalTrials.gov |
What this trial studies
This phase II clinical trial evaluates the efficacy and safety of cadonilimab, a bispecific antibody targeting PD-1 and CTLA-4, in combination with FOLFOXIRI and bevacizumab as a first-line treatment for patients with metastatic microsatellite stable (MSS) colorectal cancer. The treatment regimen includes cadonilimab administered bi-weekly alongside standard chemotherapy agents irinotecan, oxaliplatin, leucovorin, and 5-FU. The study aims to assess how well this combination can enhance immune response and improve patient outcomes compared to existing therapies.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with metastatic microsatellite stable colorectal adenocarcinoma who have not received prior systemic treatment in the metastatic setting.
Not a fit: Patients with MSI-H colorectal adenocarcinoma or those with metastatic disease that can be surgically resected may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with metastatic MSS colorectal cancer.
How similar studies have performed: Other studies have shown promising results with similar immunotherapy approaches, indicating potential for success in this novel combination.
Eligibility criteria
Show full inclusion / exclusion criteria
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: * 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
Where this trial is running
Fuzhou, Fujian
- Fujian Cancer Hospital — Fuzhou, Fujian, China (Recruiting)
Study contacts
- Study coordinator: Rongbo Lin
- Email: rongbo_lin@163.com
- Phone: 0591-83660063
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.