RecruitingPhase 2NCT06014372

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

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

Sponsor

Sun Yat-sen University

Enrollment

55 participants

Start Date

Jul 1, 2023

Study Type

INTERVENTIONAL

Conditions

Neoadjuvant Therapy Colon Cancer Immunotherapy

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing envafolimab (an immunotherapy drug) alone or combined with capecitabine and oxaliplatin (CAPEOX chemotherapy) as a treatment given before surgery for locally advanced rectal cancer, with the goal of improving the chance of complete tumor removal. **You may be eligible if...** - You are between 18 and 70 years old - You have confirmed rectal cancer - Your cancer is locally advanced (stage T3–4 or any T with lymph node involvement) - Surgery to remove the cancer completely (R0 resection) is considered achievable **You may NOT be eligible if...** - Your cancer is early-stage (T1–2 with no lymph node involvement) - Your cancer has spread to distant organs (metastasis) - You have multiple primary tumors - You are significantly underweight or malnourished (cachexia) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.