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

NCT06014372 | Recruiting Phase 2

• 1 other identifier: 2022-FXY-256-Department of CRC
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colon Cancer; Neoadjuvant Therapy; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Rate of pCR

  rate of pathological complete remission

  Time Frame: One week after surgery

Secondary Outcomes (1)

• DFS

  3 years

Other Outcomes (1)

• OS

  5 years

Study Arms (2)

Envafolimab Group

EXPERIMENTAL

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

Drug: Envafolimab

Envafolimab+CAPEOX Group

ACTIVE COMPARATOR

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.

Drug: Envafolimab; Drug: CAPEOX

Interventions

Envafolimab DRUG

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.

Envafolimab Group; Envafolimab+CAPEOX Group

CAPEOX DRUG

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.

Envafolimab+CAPEOX Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Clinical stage T1-2 N0
• Distance metastasis
• Multiple primary tumor
• Cachexy

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

envafolimab

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Zhenhai Lu, Prof

CONTACT

+862087343584; luzhh@sysucc.org.cn

Rongxin Zhang, Prof

CONTACT

+862087343584; zhangrx@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: August 28, 2023
• Study Start: July 1, 2023
• Primary Completion: July 1, 2024
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 12, 2024

Record last verified: 2024-04

Locations

CN (1)