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Trial Title:
Tislelizumab Combined With Chemotherapy (CAPOX) in the Perioperative Treatment of MSI-H/dMMR Stage II or III Colorectal Cancer
NCT ID:
NCT05841134
Condition:
MSI-H Colorectal Cancer
Tislelizumab
Oxaliplatin
Capecitabine
Conditions: Official terms:
Colorectal Neoplasms
Capecitabine
Oxaliplatin
Tislelizumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tislelizumab
Description:
Neoadjuvant treatment options:
Tislelizumab 200mg, intravenous infusion, D1, Q3W, a total of 4 cycles; Oxaliplatin
130mg/m2, intravenous infusion, D1, Q3W, 4 cycles in total; Capecitabine 1000mg/m2,
orally twice in the morning and evening, D1-14, Q3W, 4 cycles in total;
Adjuvant treatment options:
Tislelizumab 200mg, intravenous infusion, Q3W;
± Chemotherapy method (researcher judges whether to add chemotherapy according to the
comprehensive condition of the patient); Until disease progression or unacceptable
toxicity, the maximum treatment time is 12 months.
Arm group label:
Tislelizumab combined with CAPOX
Other name:
Capecitabine
Other name:
Oxaliplatin
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.
Criteria for 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;
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
June 1, 2023
Completion date:
January 31, 2027
Lead sponsor:
Agency:
The First Affiliated Hospital of Zhengzhou University
Agency class:
Other
Source:
The First Affiliated Hospital of Zhengzhou University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05841134
