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

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

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

Conditions4

Interventions2

Related trials

• A Study of Neoadjuvant Dostarlimab Plus Capecitabine Plus Oxaliplatin (CAPEOX) Vs CAPEOX With Previously Untreated T4N0 or Stage III Mismatch Repair Proficient (MMRp)/Microsatellite Stable (MSS) Colon Cancer — GlaxoSmithKline
• HDAC Inhibitor Combination With Chemoimmunotherapy in the Neoadjuvant Treatment of pMMR Locally Advanced Colon Cancer — Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Neoadjuvant FOLFOXIRI Versus CapeOX Chemotherapy for Local Advanced Rectal Cancer — Fudan University
• SCRT Followed by Camrelizumab Combined With Fluzoparib and Chemotherapy as Neoadjuvant Therapy for LARC — Huazhong University of Science and Technology
• SCRT Sequential Penpulimab in Combination With CAPEOX in the Neoadjuvant Treatment of MSS Locally Advanced Rectal Cancer — Ruijin Hospital
• Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer — GlaxoSmithKline
• A Phase I Study to Investigate the Safety and Tolerability of KGX101 Monotherapy and Combination Therapy With Envafolimab in Advanced or Metastatic Solid Tumor Patients — Kangabio AUSTRALIA LTD PTY
• Clinical Study of Envafolimab Combined With Fruquintinib and Chemotherapy for Neoadjuvant Treatment of Gastric Cancer — First Affiliated Hospital of Fujian Medical University

Browse More Trials