Toripalimab With or Without Celecoxib as Neoadjuvant Therapy in Resectable dMMR/MSI-H Colorectal Cancer

Launched by SUN YAT-SEN UNIVERSITY · Apr 22, 2019

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for patients with a specific type of colorectal cancer known as mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H). These patients often do not respond well to traditional chemotherapy, so the study is looking at the effectiveness of combining two therapies: Toripalimab, an immunotherapy that helps the body's immune system fight cancer, and Celecoxib, a type of medication that may improve the treatment's effectiveness. The goal is to see if this combination can provide better outcomes for patients before they undergo surgery to remove their tumors.

To participate in the trial, individuals must be at least 18 years old and have been diagnosed with dMMR or MSI-H colorectal cancer. They should also be in good overall health, have not previously received treatment for their cancer, and have specific imaging results showing their cancer is locally advanced but still resectable (able to be surgically removed). Participants in the trial can expect to receive the study treatments and undergo regular check-ups to monitor their health and response to the therapy. Importantly, the trial is currently recruiting participants, and those interested should discuss with their healthcare provider to see if they meet the eligibility criteria.

Gender

ALL

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 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.
• • 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 colorectal 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.