Clinical trial NCT05841134: Tislelizumab Combined With Chemotherapy (CAPOX) in the Perioperative Treatment of MSI-H/dMMR Stage II or III Colorectal Cancer
Official title: Multicenter, Single-arm, Open-label Phase II Clinical Study of Tislelizumab Combined With Chemotherapy (CAPOX) in the Perioperative Treatment of MSI-H/dMMR Stage II or III Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: MSI-H Colorectal Cancer
Tislelizumab
Oxaliplatin
Capecitabine
Lead sponsor: The First Affiliated Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a multi-center, single-arm, open-label phase II clinical trial, aiming to observe and evaluate the perioperative treatment of tislelizumab combined with chemotherapy (CAPOX) in stage II or III colorectal cancer with MSI-H/dMMR Patient efficacy and safety.


Eligibility criteria: Inclusion Criteria:

1. ECOG: 0\~1;
2. Patients with colon or rectal adenocarcinoma confirmed by histology or cytology;
3. The tissue specimens are confirmed as MSI-H by PCR or NGS. If the patients are dMMR by immunohistochemistry, they need to be confirmed as MSI-H by PCR (2021 Expert Consensus on Immunotherapy for Patients with Colorectal Cancer);
4. Patients with clinical stage II or III (cT3-T4 N0 M0 or Tany N+M0, clinically positive lymph nodes are defined as any lymph node ≥ 1.0 cm);
5. Expected survival period ≥ 12 weeks;
6. The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with follow-up visits.

Exclusion Criteria:

1. Have received anti-tumor therapy;
2. Have received PD-(L)1 or CTLA-4 treatment;
3. The patient has any active autoimmune disease or has a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis , hyperthyroidism; patients with vitiligo; asthma that has been completely remitted in childhood and does not require any intervention in adulthood can be included; patients with asthma requiring medical intervention with bronchodilators cannot be included);
4. Patients are using immunosuppressants or systemic hormone therapy to achieve the purpose of immunosuppression (dose\>10mg/day prednisone or other equivalent hormones), and continue to use within 2 weeks before enrollment;
5. Patients with any severe and/or uncontrolled diseases
6. Urine routine prompts urine protein ≥ ++, and confirmed 24-hour urine protein quantity \> 1.0g;
7. Pregnant or lactating women;
8. Patients with other malignant tumors within 5 years (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
9. Those who have a history of psychotropic drug abuse and cannot quit or patients with mental disorders;

Primary outcomes:
measure: Percentage of Participants With Pathological Complete Response (pCR)
timeFrame: Up to 24 months
Secondary outcomes:
measure: R0 resection rates
timeFrame: Up to 24 months
measure: Overall survival (OS)
timeFrame: Up to 36 months
measure: Event-free survival (EFS)
timeFrame: Up to 36 months
measure: Incidence of adverse events during the treatment and follow-up (safety)
timeFrame: until 100 days after last patient last study drug treatment
Other outcomes:
Locations:
Study officials:
References: