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

NCT04640103 | Unknown

• 1 other identifier: MSI Perioperative ICI
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

To Evaluate the Safety and Effectiveness of Immunotherapy During the Perioperative Treatment Stage in MSI-H Gastrointestinal Cancer

Outcome Measures

Primary Outcomes (1)

• Adverse event rate

  Safety

  Up to 1 years

Secondary Outcomes (3)

• Overall survival

  Up to 5 years

• Disease-free survival

  Up to 3 years

• Incidence of second tumor in patients with Lynch syndrome

  Up to 3 years

Study Arms (2)

adjuvant therapy

Patients who received immunotherapy in adjuvant treatment stage only

Other: No interventions

neoadjuvant therapy

Patients who received immunotherapy in neoadjuvant treatment stage and achieved R0 resection

Other: No interventions

Interventions

No interventions OTHER

No interventions

adjuvant therapy; neoadjuvant therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Outpatients and inpatients in Beijing Cancer Hospital

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shen Lin: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Central Study Contacts

Lin Shen, Professor

CONTACT

86-10-88196561; linshenpku@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: November 23, 2020
• Study Start: January 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: December 1, 2020

Record last verified: 2020-11

Locations

CN (1)