Neoadjuvant treatment for advanced colorectal cancer using Sintilimab
Eight Vs Four Cycles of Preoperative Neoadjuvant Sintilimab in Mismatch-repair Deficient/microsatellite Instability-high, Locally Advanced Colorectal Cancer(OPEN): a Multi-center, Open-label, Prospective Randomized Controlled Trial
This study tests if giving the immunotherapy drug Sintilimab before surgery can help people with advanced colorectal cancer have better outcomes and lower chances of their cancer coming back.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Zhengzhou University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation, sintilimab, ipilimumab, nivolumab, pembrolizumab |
| Locations | 1 site (Zheng'zhou, Henan) |
| Trial ID | NCT06698757 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients with pathologically confirmed locally advanced colorectal cancer who have dMMR or MSI-H status.
Not a fit: Patients with distant metastatic disease or those who have received prior treatments for their cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could enhance surgical outcomes and reduce recurrence rates in patients with advanced colorectal cancer.
How similar studies have performed: While the use of immunotherapy in colorectal cancer is an emerging field, this specific approach with Sintilimab in the neoadjuvant setting is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Zheng'zhou, Henan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.