Tislelizumab Combined With Chemotherapy (CAPOX) in the Perioperative Treatment of MSI-H/dMMR Stage II or III Colorectal Cancer

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Tislelizumab
  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 progressi

Первичные конечные точки

• Percentage of Participants With Pathological Complete Response (pCR) [Срок оценки: Up to 24 months]

Вторичные конечные точки (4)

• R0 resection rates [Срок оценки: Up to 24 months]
• Overall survival (OS) [Срок оценки: Up to 36 months]
• Event-free survival (EFS) [Срок оценки: Up to 36 months]
• Incidence of adverse events during the treatment and follow-up (safety) [Срок оценки: until 100 days after last patient last study drug treatment]

Критерии участия

Критерии включения

• ECOG: 0\~1;
• Patients with colon or rectal adenocarcinoma confirmed by histology or cytology;
• 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);
• 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);
• Expected survival period ≥ 12 weeks;
• The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with follow-up visits.

Критерии исключения

• Have received anti-tumor therapy;
• Have received PD-(L)1 or CTLA-4 treatment;
• 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);
• 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;
• Patients with any severe and/or uncontrolled diseases
• Urine routine prompts urine protein ≥ ++, and confirmed 24-hour urine protein quantity > 1.0g;
• Pregnant or lactating women;
• Patients with other malignant tumors within 5 years (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
• Those who have a history of psychotropic drug abuse and cannot quit or patients with mental disorders;

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT05841134 · T-CAPOX-MSI-H-CRC-

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗