An observational study in To Evaluate the Safety and Effectiveness of Immunotherapy During the Perioperative Treatment Stage in MSI-H Gastrointestinal Cancer, sponsored by Shen Lin. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-01.
Sponsored by Shen Lin · Observational
Gastrointestinal cancer like Gastric cancer and colorectal cancer are high-incidence tumors worldwide. Surgery is the only curable way. Perioperative treatment can improve the survival of patients. Microsatellite instability-high（MSI-H）are a special subtype of gastrointestinal tumors, accounting for about 15-22%. According to current research, patients with this type of gastrointestinal tumors cannot benefit from traditional perioperative chemotherapy, which directly affects the long-term survival of patients. Because patients with MSI-H have a unique tumor immune microenvironment, thus they are more likely to benefit from immunotherapy. Current studies have confirmed that the use of immunotherapy during palliative care can prolong the survival of patients with MSI-H. In the neoadjuvant treatment stage, according to the previous clinical practice of our center, the use of immunotherapy can make some patients achieve complete postoperative pathological remission. However, in the perioperative treatment stage, the value of immunotherapy is still lack of powerful clinical evidence.
Based on this, our group intends to start an observational study to prospectively enroll patients with MSI-H gastrointestinal tumor using immunotherapy during the perioperative period.The primary endpoint is safety while survival outcomes as secondary endpoints. In order to evaluate the safety and effectiveness of immunotherapy during the perioperative treatment stage in MSI-H gastrointestinal cancer
779 studies on the registry are indexed under Gastrointestinal Neoplasms; 231 are open to participants now.
This study's planned enrollment of 100 is below the median of 197 across 176 observational studies indexed under Gastrointestinal Neoplasms.
Browse Gastrointestinal Neoplasms studies →Shen Lin is the lead sponsor of 10 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Outpatients and inpatients in Beijing Cancer Hospital
Exclusion Criteria:
Patients who received immunotherapy in adjuvant treatment stage only
Other: No interventions
Patients who received immunotherapy in neoadjuvant treatment stage and achieved R0 resection
Other: No interventions
No interventions
Adverse event rate
Safety
Time frame: Up to 1 years
Overall survival
From the time of enrollment to death caused by any reason
Time frame: Up to 5 years
Disease-free survival
From the time of enrollment to disease recurrence or death caused by any reason
Time frame: Up to 3 years
Incidence of second tumor in patients with Lynch syndrome
Time frame: Up to 3 years
This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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Shen Lin