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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06014372
Other study ID # 2022-FXY-256-Department of CRC
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date July 1, 2023
Est. completion date July 1, 2026

Study information

Verified date April 2024
Source Sun Yat-sen University
Contact Zhenhai Lu, Prof
Phone +862087343584
Email luzhh@sysucc.org.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 55
Est. completion date July 1, 2026
Est. primary completion date July 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Intervention

Drug:
Envafolimab
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.
CAPEOX
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.

Locations

Country Name City State
China Sun Yat-Sen University Cancer Center Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other OS O Overall survival 5 years
Primary Rate of pCR rate of pathological complete remission Time Frame: One week after surgery
Secondary DFS Disease free survival 3 years
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