Neoadjuvant treatment for advanced colorectal cancer using Sintilimab

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of Sintilimab, an immunotherapy drug, as a neoadjuvant treatment for patients with locally advanced colorectal cancer that is mismatch-repair deficient or microsatellite instability-high. The study focuses on patients who are not in urgent need of surgery and have specific pathological confirmations of their cancer. By administering Sintilimab before surgery, the trial aims to improve surgical outcomes and reduce the risk of recurrence in this patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Affiliated Hospital of Zhengzhou University
  Zheng'zhou, Henan, China Recruiting

Study contacts

• Study coordinator: Yugui Lian, M.D.
• Email: fcclianyg@zzu.edu.cn
• Phone: +86 0371-66279076

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.