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

Sun Yat-sen University

Status and phase: Enrolling; Phase 2

Conditions: Immunotherapy; Colon Cancer; Neoadjuvant Therapy

Treatments: Drug: CAPEOX; Drug: Envafolimab

Study type: Interventional

Funder types: Other

Identifiers

NCT06014372

2022-FXY-256-Department of CRC

Details and patient eligibility

About

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.

Enrollment: 55 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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55 participants in 2 patient groups

Envafolimab Group

Experimental group

Description:

Patients diagnosed with colon cancer, with T stage determined as 3-4 based on enhanced MR imaging, or with any T stage accompanied by imaging findings suggestive of lymph node metastasis, and excluding patients with distant metastasis, who are confirmed to have microsatellite instability-high (MSI-H)/deficient mismatch repair (dMMR) colon cancer, will be enrolled in Group A

Treatment:

Drug: Envafolimab

Envafolimab+CAPEOX Group

Active Comparator group

Description:

Patients diagnosed with colon adenocarcinoma, with T stage determined as 3-4 based on enhanced MR imaging, or with any T stage accompanied by imaging findings suggestive of lymph node metastasis, and excluding patients with distant metastasis, who are confirmed to have microsatellite stable (MSS)/proficient mismatch repair (pMMR) colon cancer, will be enrolled in Group B.

Treatment:

Drug: CAPEOX

Drug: Envafolimab