Colo-rectal Cancer (dMMR/MSI-H CRC)NCT07352280
Neoadjuvant Therapy With Tislelizumab for dMMR/MSI-H Stage II-III Colorectal Cancer
An observational study of Colo-rectal Cancer (dMMR/MSI-H CRC), run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This study is a prospective, observational, real-world investigation. This study will evaluate the efficacy and safety of tislelizumab monotherapy before surgery in patients with mismatch repair deficient or microsatellite instability high (dMMR/MSI-H) locally advanced colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colo-rectal Cancer (dMMR/MSI-H CRC)
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2026to 31 Dec 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with colorectal adenocarcinoma registered and treated at the Cancer Hospital Chinese Academy of Medical Sciences.
Who may be able to join
- Age ≥ 18 years, ECOG performance status score 0-2.
- Pathologically confirmed stage II-III colorectal adenocarcinoma (according to AJCC 8th edition).
- Histologically confirmed mismatch repair deficient or genetic testing confirmed microsatellite instability high tumor.
- Signed written informed consent.
Who cannot join
- The patient has a history of other serious conditions rendering them unsuitable for surgery.
- Subjects with the following conditions: active autoimmune diseases, active infectious diseases, inflammatory bowel diseases; requiring long-term glucocorticoid or immunosuppressive therapy during treatment; history of immunodeficiency; history of organ transplantation or haematopoietic stem cell transplantation; severe interstitial pneumonia or pulmonary fibrosis.
- Known hypersensitivity to any component or excipient of tislelizumab or other PD-1/PD-L1 agents.
- Other conditions deemed unsuitable for inclusion by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Undefined
Letian Zhang, 8618226671177, 1010037746@qq.com
About this study
Official title: An Observational, Prospective, Real-World Study of Tislelizumab as Neoadjuvant Therapy for dMMR/MSI-H Stage II-III Colorectal Cancer
This study is a prospective, observational, real-world investigation. This study will evaluate the efficacy and safety of tislelizumab monotherapy before surgery in patients with mismatch repair deficient or microsatellite instability high (dMMR/MSI-H) locally advanced colorectal cancer.
All patients will receive three cycles of tislelizumab neoadjuvant therapy followed by curative surgery. Postoperatively, based on surgical pathology, patients will receive adjuvant therapy with a regimen selected by the investigator or adopt a watch-and-wait strategy. The investigators will conduct a 5-year prospective follow-up.
The investigators plan to enroll approximately 30 subjects.
- Conditions
- Colo-rectal Cancer (dMMR/MSI-H CRC)
- Keywords
- tislelizumab, dMMR/MSI-H stage II-III colorectal cancer, neoadjuvant therapy
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| dMMR/MSI-H CRC | Patients with dMMR/MSI-H stage II-III colorectal cancer who received neoadjuvant treatment with tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response
The lack of all signs of cancer in tissue samples removed during surgery or biopsy after neoadjuvant treatment with tislelizumab.
Measured: Up to 3 weeks after surgery
Treatment emergent adverse events
Treatment emergent adverse events (TEAE) are undesirable events not present prior to medical treatment, or an already present event that worsens either in intensity or frequency following the treatment.
Measured: Up to 90 days after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
Secondary outcomes (5)
Clinical complete response
Measured: Up to 6 weeks after 3 cycles (each cycle is 21 days) of neoadjuvant treatment
Event free survival
Measured: Up to 2 years
Overall survival
Measured: Up to 5 years
Treatment related adverse events
Measured: Up to 90 days after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
Immunotherapy related adverse events
Measured: Up to 90 days after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Feb 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colo-rectal Cancer (dMMR/MSI-H CRC)Studies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LIN YANG, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07352280
- Sponsor's protocol ID
- NCC5791
- Status last verified
- Jan 2026
- First submitted
- 11 Jan 2026
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational, Prospective, Real-World Study of Tislelizumab as Neoadjuvant Therapy for dMMR/MSI-H Stage II-III Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07352280
- Acronym / sponsor ID
- NCC5791
- Conditions
- Colo-rectal Cancer (dMMR/MSI-H CRC)
- Keywords
- tislelizumab, dMMR/MSI-H stage II-III colorectal cancer, neoadjuvant therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 20 Jan 2026 (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.
This study is a prospective, observational, real-world investigation. This study will evaluate the efficacy and safety of tislelizumab monotherapy before surgery in patients with mismatch repair deficient or microsatellite instability high (dMMR/MSI-H) locally advanced colorectal cancer.
All patients will receive three cycles of tislelizumab neoadjuvant therapy followed by curative surgery. Postoperatively, based on surgical pathology, patients will receive adjuvant therapy with a regimen selected by the investigator or adopt a watch-and-wait strategy. The investigators will conduct a 5-year prospective follow-up.
The investigators plan to enroll approximately 30 subjects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dMMR/MSI-H CRC | – | –Patients with dMMR/MSI-H stage II-III colorectal cancer who received neoadjuvant treatment with tislelizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with colorectal adenocarcinoma registered and treated at the Cancer Hospital Chinese Academy of Medical Sciences.
Key inclusion criteria (4 listed)
- Age ≥ 18 years, ECOG performance status score 0-2.
- Pathologically confirmed stage II-III colorectal adenocarcinoma (according to AJCC 8th edition).
- Histologically confirmed mismatch repair deficient or genetic testing confirmed microsatellite instability high tumor.
- Signed written informed consent.
Key exclusion criteria (4 listed)
- The patient has a history of other serious conditions rendering them unsuitable for surgery.
- Subjects with the following conditions: active autoimmune diseases, active infectious diseases, inflammatory bowel diseases; requiring long-term glucocorticoid or immunosuppressive therapy during treatment; history of immunodeficiency; history of organ transplantation or haematopoietic stem cell transplantation; severe interstitial pneumonia or pulmonary fibrosis.
- Known hypersensitivity to any component or excipient of tislelizumab or other PD-1/PD-L1 agents.
- Other conditions deemed unsuitable for inclusion by the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pathological complete response
Time frame: Up to 3 weeks after surgery
The lack of all signs of cancer in tissue samples removed during surgery or biopsy after neoadjuvant treatment with tislelizumab.
Treatment emergent adverse events
Time frame: Up to 90 days after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
Treatment emergent adverse events (TEAE) are undesirable events not present prior to medical treatment, or an already present event that worsens either in intensity or frequency following the treatment.
5 secondary outcomes
Clinical complete response
Time frame: Up to 6 weeks after 3 cycles (each cycle is 21 days) of neoadjuvant treatment
Event free survival
Time frame: Up to 2 years
Overall survival
Time frame: Up to 5 years
Treatment related adverse events
Time frame: Up to 90 days after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
Immunotherapy related adverse events
Time frame: Up to 90 days after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
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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.
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 Colo-rectal Cancer (dMMR/MSI-H CRC), run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 19 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lin Yang (8601087788145, linyangcicams@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response (time frame: Up to 3 weeks after surgery). The study lists 2 primary outcomes in all. 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 19 Feb 2026.