Using Envafolimab with or without CAPEOX for advanced colorectal cancer treatment
A Prospective, Single-center, Multi-cohort Study of Envolimab Monotherapy or Envafolimab in Combination With CAPEOX as Neoadjuvant Therapy for Locally Advanced Colorectal Cancer.
This study is testing if a new drug called envafolimab, alone or with a standard chemotherapy combination, can help people with advanced colorectal cancer that has certain genetic features.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 55 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | Envafolimab, chemotherapy, immunotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06014372 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of envafolimab, a PD-L1 monoclonal antibody, either alone or in combination with CAPEOX as neoadjuvant therapy for patients with locally advanced colorectal cancer that exhibits microsatellite instability (MSI-H/dMMR). The study aims to address the low responsiveness to traditional neoadjuvant chemotherapy in this patient population, which has shown modest benefits from immunotherapy in preliminary studies. Participants will be closely monitored for treatment outcomes and potential side effects.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with pathologically confirmed rectal cancer at clinical stage T3-4 or T any N1.
Not a fit: Patients with early-stage colorectal cancer (T1-2 N0) or those with distant metastasis may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for patients with locally advanced MSI-H/dMMR colorectal cancer.
How similar studies have performed: Preliminary studies have shown promising results for neoadjuvant immunotherapy in similar patient populations, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pathological confirmed rectal cancer * Clinical stage T3-4 or T any N1 * With or without MRF positivity, with or without EMVI positivity * R0 resection is estimated * Age ranged from 18 to 70 Exclusion Criteria: * Clinical stage T1-2 N0 * Distance metastasis * Multiple primary tumor * Cachexy
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-Sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Zhenhai Lu, Prof
- Email: luzhh@sysucc.org.cn
- Phone: +862087343584
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.