An Observational Study of Perioperative Immunotherapy in MSI-H Gastrointestinal Tumors

An Observational Study Evaluating the Safety and Effectiveness of Perioperative Immunotherapy in Microsatellite Instability-high Gastrointestinal Tumors

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

Study Overview

• Status: Not yet recruiting
• Conditions: To Evaluate the Safety and Effectiveness of Immunotherapy During the Perioperative Treatment Stage in MSI-H Gastrointestinal Cancer
• Intervention / Treatment: Other: No interventions

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Beijing Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Outpatients and inpatients in Beijing Cancer Hospital

Description

Inclusion Criteria:

1. ≥18 years old,diagnosed as gastric or colorectal cancer by pathology;
2. Diagnosed as a mismatch repair deficient by immunohistochemistry,or diagnosed as microsatellite instability-high by polymerase chain reaction(PCR) or next-generation sequencing(NGS);
3. Suitable for tumor radical resection;
4. Join this trial voluntarily,and could sign an informed consent form;
5. With good compliance.

Exclusion Criteria:

1. Do not use immunotherapy containing PD-1/PD-L1 antibody during the perioperative period;
2. Simultaneous diagnosis of dual primary tumors, and the second tumor cannot be resected radically, or the second tumor is not dMMR/MSI-H;
3. Complicate with uncontrollable immune system diseases;
4. Patients who need to use glucocorticoids and other immunosuppressive agents for a long time;
5. Patients who received live vaccines or live attenuated vaccines within 30 days before the medication, except for inactivated vaccines;
6. Those who cannot provide detailed medical records or cannot cooperate with follow-up.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
adjuvant therapy; Patients who received immunotherapy in adjuvant treatment stage only	Other: No interventions; No interventions
neoadjuvant therapy; Patients who received immunotherapy in neoadjuvant treatment stage and achieved R0 resection	Other: No interventions; No interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse event rate	Safety	Up to 1 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	From the time of enrollment to death caused by any reason	Up to 5 years
Disease-free survival	From the time of enrollment to disease recurrence or death caused by any reason	Up to 3 years
Incidence of second tumor in patients with Lynch syndrome		Up to 3 years

Collaborators and Investigators

• Sponsor: Shen Lin

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2021
• Primary Completion (ANTICIPATED): December 31, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: November 16, 2020
• First Submitted That Met QC Criteria: November 20, 2020
• First Posted (ACTUAL): November 23, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 1, 2020
• Last Update Submitted That Met QC Criteria: November 26, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms
• Other Study ID Numbers: MSI Perioperative ICI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No