Envafolimab as Neoadjuvant Immuntherapy in Resectable Local Advanced dMMR/MSI-H Colorectal Cancer

Launched by THIRD AFFILIATED HOSPITAL, SUN YAT-SEN UNIVERSITY · May 10, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Envafolimab, which is an immunotherapy drug, for patients with a specific type of colorectal cancer known as mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H). These types of cancer do not respond well to traditional chemotherapy, and the trial aims to see if this new treatment can help shrink tumors before surgery. The trial is looking for participants who are between 18 and 70 years old, have a confirmed diagnosis of colorectal cancer, and have not received prior treatment for their cancer.

Participants in this trial can expect to receive Envafolimab, and their progress will be closely monitored. They will undergo scans and tests to ensure their cancer is suitable for the study. It's important to note that those with certain health conditions, previous cancers, or recent treatments may not be eligible to join. This study hopes to find a safe and effective way to treat this challenging type of colorectal cancer, potentially improving outcomes for patients.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Willing and able to provide written informed consent.
• • 2. Histological or cytological documentation of adenocarcinoma of the colon or rectum.
• • 3. Tumor tissues were identified as mismatch repair-deficient (dMMR) by immunohistochemistry (IHC) method or microsatellite instability-high (MSI-H) by polymerase chain reaction (PCR).
• • 4. Male or female subjects \> 18 years \< 70 of age.
• • 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• • 6. Determined CT or MRI scans (done within 14 days of registration) of the chest, abdomen and pelvis: locally advanced (cT3-4 or cN1-2 \[with the definition of a clinically positive lymph node being any node ≥ 1.0 cm\]).
• • 7. Non complicated primary tumor (obstruction, perforation, bleeding).
• • 8. No previous any systemic anticancer therapy for colorectal cancer disease or radiologic evaluation of tumor regression \< 20% or unacceptable toxic effects during neoadjuvant chemotherapy.
• • 9. Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment.
• Exclusion Criteria:
• • 1. Previous or concurrent cancer that is distinct in primary site or histology from colon cancer within 5 years prior to randomization.
• • 2. Significant cardiovascular disease including unstable angina or myocardial infarction within 6 months before initiating study treatment.
• • 3. Heart failure grade III/IV (NYHA-classification).
• • 4. Unresolved toxicity higher than CTCAE v.4.0 Grade 1 attributed to any prior therapy/procedure.
• • 5. Subjects with known allergy to the study drugs or to any of its excipients.
• • 6. Current or recent (within 4 weeks prior to starting study treatment) treatment of another investigational drug or participation in another investigational study.
• • 7. Breast- feeding or pregnant women
• • 8. Lack of effective contraception.
• • 9. Previously received anti-programmed death-1 (PD-1) or its ligand (PD-L1) antibody, anti-cytotoxic T lymphocyte-associated antigen 4 (cytotoxic T-lymphocyte-associated Protein 4, CTLA-4) antibody or other drug/antibody that acts on T cell costimulation or checkpoint pathways.
• • 10. With any distant metastasis.