Colon Cancer, Neoadjuvant Therapy, Immunotherapy
Conditions
Brief summary
There exists substantial evidence suggesting that patients diagnosed with MSI-H/dMMR colorectal cancer can derive benefits from immunotherapy in the management of advanced colorectal cancer. In cases of locally advanced colorectal cancer exhibiting microsatellite instability (dMMR/MSI-H), patients exhibit low responsiveness to neoadjuvant chemotherapy, resulting in minimal rates of complete tumor remission and downstaging. Nevertheless, initial exploratory studies, characterized by modest sample sizes, reveal a favorable therapeutic effect of neoadjuvant immunotherapy in this particular patient population. Envafolimab monoclonal antibody, the first PD-L1 antibody developed and manufactured in China, possesses noteworthy practical and societal value in the context of exploratory clinical research on neoadjuvant immunotherapy for locally advanced MSI-H/dMMR colorectal cancer patients. The objective of this study is to evaluate the safety and efficacy of envafolimab monoclonal antibody (PD-L1) as neoadjuvant therapy for locally advanced MSI-H/dMMR colorectal cancer through a prospective, multi-cohort phase II clinical trial. Additionally, this study aims to investigate the effectiveness and safety of envafolimab monoclonal antibody in combination with CAPEOX as a neoadjuvant treatment regimen for locally advanced pMMR colorectal cancer.
Interventions
DRUGEnvafolimab
Upon confirming eligibility based on inclusion criteria and obtaining signed informed consent, the patient will be administered Envafolimab at a dose of 300mg every 3 weeks (Q3W) for a total of 4 cycles, starting on Day 1.
DRUGCAPEOX
The neoadjuvant treatment regimen will consist of Oxaliplatin at a dose of 130mg/m2, administered intravenously over a period of more than 2 hours on Day 1, every 3 weeks; and Capecitabine at a dose of 1000mg/m2, orally, twice daily from Day 1 to Day 14, every 3 weeks, for a total of 4 cycles.
Sponsors
Sun Yat-sen University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of pCR | Time Frame: One week after surgery | rate of pathological complete remission |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DFS | 3 years | Disease free survival |
Other
| Measure | Time frame | Description |
|---|---|---|
| OS | 5 years | O Overall survival |
Countries
China
Contacts
Primary ContactZhenhai Lu, Prof
Backup ContactRongxin Zhang, Prof
Outcome results
None listed