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

NCT ID: NCT05841134

Last Updated: 2023-05-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2027-01-31

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.

Conditions

MSI-H Colorectal Cancer; Tislelizumab; Oxaliplatin; Capecitabine

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tislelizumab combined with CAPOX

Successfully screened subjects will receive 4 cycles of neoadjuvant therapy with tislelizumab combined with chemotherapy (CAPOX) before surgery； undergo radical surgery 4-6 weeks after the end of the last medication; tislelizumab will be given after surgery Monoclonal antibody ± chemotherapy adjuvant therapy (the investigator judges whether to add chemotherapy based on the patient's comprehensive condition), until disease progression or unacceptable toxicity, the longest treatment is 12 months.

Group Type: EXPERIMENTAL

Tislelizumab

Intervention Type: 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.

Interventions

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 progression or unacceptable toxicity, the maximum treatment time is 12 months.

Intervention Type: DRUG

Other Intervention Names

Capecitabine; Oxaliplatin

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role: lead

Responsible Party

Feng Wang

Head of the oncology ward

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

T-CAPOX-MSI-H-CRC-

Identifier Type: -

Identifier Source: org_study_id