Neoadjuvant Toripalimab With or Without Celecoxib in dMMR/MSI-H Colorectal Cancer (NCT03926338) | Clinical Trial Compass
RecruitingPhase 2
Neoadjuvant Toripalimab With or Without Celecoxib in dMMR/MSI-H Colorectal Cancer
China270 participantsStarted 2019-05-10
Plain-language summary
Colorectal cancer of Mismatch Repair-deficient (dMMR)/ Microsatellite Instability-high (MSI-H) accounts for approximately 15% of all colorectal cancer patients, with a higher proportion in right colon cancer. Previous studies have found that colon cancer patients with dMMR/MSI-H cannot benefit from 5-fluorouracil (5-FU) adjuvant chemotherapy. Once patients have distant metastases, they are not sensitive to traditional palliative chemotherapy, and the prognosis is significantly worse than that of mismatch repair-proficient (pMMR)/microsatellite stability (MSS). A phase II clinical study of anti-PD-1 immunotherapy based on mismatch repair (MMR) status published in γN Engl J Medγ showed that the objective response rate (ORR) of advanced colorectal cancer patients with dMMR received anti-PD-1 is 40%, and a longer response time can be obtained compared to conventional chemotherapy.
Anti-PD-1 neoadjuvant therapy has proven to be safe and feasible in lung cancer, bladder cancer and malignant melanoma, and can achieve more than 40% of major pathological response. However, there are no reports of anti-PD-1 neoadjuvant therapy for the dMMR/MSI-H colorectal cancer. Therefore, the aim of this study was to find the best multidisciplinary treatment for resectable colorectal cancer patient with the dMMR/MSI-H phenotype and to explore whether cyclooxygenase (COX) inhibitors combined with anti-PD-1 monoclonal antibody (mAb) could further improve efficacy.
Who can participate
Age range18 Years β 75 Years
SexALL
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Inclusion criteria
β. Willing and able to provide written informed consent.
β. Histological or cytological documentation of adenocarcinoma of the colon or rectum.
β. Tumor tissues were identified as mismatch repair-deficient (dMMR) by immunohistochemistry (IHC) method or microsatellite instability-high (MSI-H) by polymerase chain reaction (PCR).
β. Male or female subjects aged 18 to 75 years.
β. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
β. Determined CT or MRI scans (done within 14 days of registration) of the chest, abdomen and pelvis: locally advanced (cT3-4 or cN1-2 \[with the definition of a clinically positive lymph node being any node β₯ 1.0 cm\]).
β. Non complicated primary tumor (obstruction, perforation, bleeding).
β. No previous any systemic anticancer therapy for colorectal cancer disease.
Exclusion criteria
β
What they're measuring
1
Pathological complete response (pCR) rates (PICC-1 and PICC-2 cohorts)
β. Unresolved toxicity higher than CTCAE v.4.0 Grade 1 attributed to any prior therapy/procedure.
β. Subjects with known allergy to the study drugs or to any of its excipients.
β. Current or recent (within 4 weeks prior to starting study treatment) treatment of another investigational drug or participation in another investigational study.