Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dMMR/MSI-H CRC | Patients with dMMR/MSI-H stage II-III colorectal cancer who received neoadjuvant treatment with tislelizumab |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Pathological complete response | The lack of all signs of cancer in tissue samples removed during surgery or biopsy after neoadjuvant treatment with tislelizumab. | 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. | Up to 90 days after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical complete response | Up to 6 weeks after 3 cycles (each cycle is 21 days) of neoadjuvant treatment | |
| Event free survival | Up to 2 years | |
| Overall survival |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients with colorectal adenocarcinoma registered and treated at the Cancer Hospital Chinese Academy of Medical Sciences.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lin Yang | Contact | 8601087788145 | linyangcicams@126.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Recruiting | Beijing | Undefined | China |
Not provided
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Blood, tumours
| Up to 5 years |
| Treatment related adverse events | Up to 90 days after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment |
| Immunotherapy related adverse events | Up to 90 days after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |