Envafolimab Monotherapy or Envafolimab + CAPEOX as Neoadjuvant Therapy for Locally Advanced Colorectal Cancer

Colon Cancer Clinical Trial

Official title:

A Prospective, Single-center, Multi-cohort Study of Envolimab Monotherapy or Envafolimab in Combination With CAPEOX as Neoadjuvant Therapy for Locally Advanced Colorectal Cancer.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06014372
• Other study ID #: 2022-FXY-256-Department of CRC
• Status: Recruiting
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Colon Cancer
• Colorectal Neoplasms
• Immunotherapy
• Neoadjuvant Therapy

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