To Evaluate the Safety and Effectiveness of Immunotherapy During the Perioperative Treatment Stage in MSI-H Gastrointestinal CancerNCT04640103
An Observational Study of Perioperative Immunotherapy in MSI-H Gastrointestinal Tumors
An observational study of To Evaluate the Safety and Effectiveness of Immunotherapy During the Perioperative Treatment Stage in MSI-H Gastrointestinal Cancer, run by Shen Lin at 1 site in China.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- To Evaluate the Safety and Effectiveness of Immunotherapy During the Perioperative Treatment Stage in MSI-H Gastrointestinal Cancer
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Outpatients and inpatients in Beijing Cancer Hospital
Who may be able to join
- ≥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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Being tested
- No interventions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionsOther
No interventions
| Study group | Role | What they receive |
|---|---|---|
| adjuvant therapy | Patients who received immunotherapy in adjuvant treatment stage only Receives: Other: No interventions | |
| neoadjuvant therapy | Patients who received immunotherapy in neoadjuvant treatment stage and achieved R0 resection Receives: Other: No interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event rate
Safety
Measured: Up to 1 years
Secondary outcomes (3)
Overall survival
From the time of enrollment to death caused by any reason
Measured: Up to 5 years
Disease-free survival
From the time of enrollment to disease recurrence or death caused by any reason
Measured: Up to 3 years
Incidence of second tumor in patients with Lynch syndrome
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start1 Jan 2021 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Evaluate the Safety and Effectiveness of Immunotherapy During the Perioperative Treatment Stage in MSI-H Gastrointestinal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shen Lin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shen Lin, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04640103
- Sponsor's protocol ID
- MSI Perioperative ICI
- Status last verified
- Nov 2020
- First submitted
- 16 Nov 2020
- Last updated
- 1 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study Evaluating the Safety and Effectiveness of Perioperative Immunotherapy in Microsatellite Instability-high Gastrointestinal Tumors
- ClinicalTrials.gov ID
- NCT04640103
- Acronym / sponsor ID
- MSI Perioperative ICI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shen LinUniversity, hospital or other
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 23 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| adjuvant therapy | – | Other: No interventionsPatients who received immunotherapy in adjuvant treatment stage only |
| neoadjuvant therapy | – | Other: No interventionsPatients who received immunotherapy in neoadjuvant treatment stage and achieved R0 resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Outpatients and inpatients in Beijing Cancer Hospital
Key inclusion criteria (5 listed)
- ≥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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionsNo interventions | Other | adjuvant therapy, neoadjuvant therapy |
Primary outcome
Adverse event rate
Time frame: Up to 1 years
Safety
3 secondary outcomes
Overall survival
Time frame: Up to 5 years
Disease-free survival
Time frame: Up to 3 years
Incidence of second tumor in patients with Lynch syndrome
Time frame: Up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of To Evaluate the Safety and Effectiveness of Immunotherapy During the Perioperative Treatment Stage in MSI-H Gastrointestinal Cancer, run by Shen Lin at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lin Shen, Professor (86-10-88196561, linshenpku@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse event rate (time frame: Up to 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2020; AzTrials last refreshed its copy on 7 Nov 2026.