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NCT Number: NCT05841134

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

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.

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Key information

Conditions

MSI-H Colorectal Cancer Capecitabine Oxaliplatin Tislelizumab

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;

Treatment and study plan

Tislelizumab

Drug

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.

Other names: Capecitabine, Oxaliplatin

Primary outcomes

  1. Percentage of Participants With Pathological Complete Response (pCR)

    Time frame: Up to 24 months

    After receiving tislelizumab combined with CAPOX neoadjuvant, the rate of pathological complete remission (after neoadjuvant therapy, for those who insist on organ preservation, combined with imaging and endoscopic examination to achieve cCR, and the biopsy result of the microscope is pathological Complete remission can be judged as pCR)

Secondary outcomes

  1. R0 resection rates

    Time frame: Up to 24 months

    The proportion of patients achieved a complete resection with negative margin.

  2. Overall survival (OS)

    Time frame: Up to 36 months

    Defined as the time from randomization to death from any cause.

  3. Event-free survival (EFS)

    Time frame: Up to 36 months

    Event-free survival is the time from the beginning of enrollment to the occurrence of any event, including death, disease progression, change to chemotherapy, change to chemotherapy, addition of other treatments, and occurrence of fatal or intolerable side effects

  4. Incidence of adverse events during the treatment and follow-up (safety)

    Time frame: until 100 days after last patient last study drug treatment

    Adverse events will be assessed during treatment and follow-up.

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Zhengzhou University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2027
First posted
May 3, 2023
Registry last updated
May 9, 2023

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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