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โ† Trials
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Different Cycles of Preoperative Neoadjuvant Sintilimab in Mismatch-repair Deficient/microsatellite Instability-high, Locally Advanced Colorectal Cancer

RecruitingPhase 2Ages 18 Years - 75 YearsAllYugui Lian
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In plain words

What the trial is, and whether it could suit you

Colorectal cancer is one of the most common malignant tumors, accounting for approximately 10% of new cancer cases and cancer-related deaths worldwide each year. In recent years, with the development of industrialization and urbanization, the increase in the number of elderly patients, and changes in dietary structure and lifestyle habits, the incidence and mortality rates of colorectal cancer in China have risen significantly. Some patients are already in locally advanced or late stages at the time of diagnosis, making treatment more difficult. Among them, patients with MSI-H/dMMR colorectal cancer account for about 10% to 15% of the total. Neoadjuvant therapy for rectal cancer primarily targets resectable mid-to-low rectal cancer patients with T3/4 and any N stage. Currently, neoadjuvant therapy for rectal cancer mainly involves chemoradiotherapy, while patients with a low risk of rec

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * has pathologically confirmed colon cancer or upper rectal cancer (with the lower edge of the tumor more than 10 cm from the anal verge); clinical stage cT3/T4 or N+ * no urgent need for surgery due to bleeding, perforation, or obstruction * immunohistochemistry of tumor biopsy indicating deficient mismatch repair (dMMR), defined by the loss of expression of one or more of the four proteins MSH1, MSH2, MSH6, and PMS2; or genetic testing indicating MSI-H Exclusion Criteria: * Has distant metastatic disease. * Has received prior medical therapy (chemotherapy, immunotherapy, biologic, or targeted therapy), radiation therapy or surgery for management of colon cancer * Has undergone any major surgical procedure, open biopsy, or experienced significant traumatic injury within 28 days prior to randomization * Is receiving any other anticancer or experimental therapy. No other experimental therapies (including but not limited to chemotherapy, radiation, hormonal treatment, antibody therapy, immunotherapy, gene therapy, vaccine therapy, or other experimental drugs) of any kind are permitted while the participant is receiving study intervention * There is a history of illness or evidence of disease, treatment, or abnormal laboratory test values that could potentially interfere with the trial results or hinder the subject's full participation in the study, or any other conditions deemed unsuitable for inclusion by the investigator. * The investigator believes there are other potential risks that make the subject unsuitable for participation in this study.
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What it tests

  • Sintilimab
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Where

1 site
The First Affiliated Hospital of Zhengzhou University
Zheng'zhou, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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