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

Sponsor
Shen Lin (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04640103
Collaborator
(none)
100
1
35.9
2.8

Study Details

Study Description

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

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
An Observational Study Evaluating the Safety and Effectiveness of Perioperative Immunotherapy in Microsatellite Instability-high Gastrointestinal Tumors
Anticipated Study Start Date :
Jan 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Adverse event rate [Up to 1 years]

    Safety

Secondary Outcome Measures

  1. Overall survival [Up to 5 years]

    From the time of enrollment to death caused by any reason

  2. Disease-free survival [Up to 3 years]

    From the time of enrollment to disease recurrence or death caused by any reason

  3. Incidence of second tumor in patients with Lynch syndrome [Up to 3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Cancer Hospital Beijing Beijing China 100142

Sponsors and Collaborators

  • Shen Lin

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shen Lin, Professor, Peking University
ClinicalTrials.gov Identifier:
NCT04640103
Other Study ID Numbers:
  • MSI Perioperative ICI
First Posted:
Nov 23, 2020
Last Update Posted:
Dec 1, 2020
Last Verified:
Nov 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 1, 2020