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NCT Number: NCT07352280

Neoadjuvant Therapy With Tislelizumab 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.

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Key information

Conditions

Colo-rectal Cancer (dMMR/MSI-H CRC) Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Undefined, China

Location status: Recruiting

Location contact

Letian Zhang

CONTACT

[email protected]

8618226671177

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Clinical complete response

    Time frame: Up to 6 weeks after 3 cycles (each cycle is 21 days) of neoadjuvant treatment

  2. Event free survival

    Time frame: Up to 2 years

  3. Overall survival

    Time frame: Up to 5 years

  4. Treatment related adverse events

    Time frame: Up to 90 days after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment

  5. Immunotherapy related adverse events

    Time frame: Up to 90 days after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Lin Yang

CONTACT

[email protected]

8601087788145

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Official study title

An Observational, Prospective, Real-World Study of Tislelizumab as Neoadjuvant Therapy for dMMR/MSI-H Stage II-III Colorectal Cancer

Important dates

Study start
2026
Primary completion
2027
Study completion
2032
First posted
Jan 20, 2026
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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