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Clinical Trial NCT05841134 for MSI-H Colorectal Cancer, Tislelizumab, Oxaliplatin, Capecitabine is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Tislelizumab Combined With Chemotherapy (CAPOX) in the Perioperative Treatment of MSI-H/dMMR Stage II or III Colorectal Cancer Phase 2 25 Multi-Center Open-Label

Not yet recruiting
Clinical Trial NCT05841134 is designed to study Treatment for MSI-H Colorectal Cancer, Tislelizumab, Oxaliplatin, Capecitabine. This Phase 2 interventional study is not yet recruiting. Enrollment is planned to begin on June 1, 2023 until the study accrues 25 participants. Led by The First Affiliated Hospital of Zhengzhou University, this study is expected to complete by January 31, 2027. The latest data from ClinicalTrials.gov was last updated on May 9, 2023.
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.
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

Conditions
MSI-H Colorectal CancerTislelizumabOxaliplatinCapecitabine
Other Study IDs
  • T-CAPOX-MSI-H-CRC-
NCT ID Number
NCT05841134
Start Date (Actual)
2023-06-01
Last Update Posted
2023-05-09
Completion Date (Estimated)
2027-01-31
Enrollment (Estimated)
25
Study Type
Interventional
PHASE
Phase 2
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalTislelizumab 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 di...Show More
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 a...Show More
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Percentage of Participants With Pathological Complete Response (pCR)
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)
Up to 24 months
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
R0 resection rates
The proportion of patients achieved a complete resection with negative margin.
Up to 24 months
Overall survival (OS)
Defined as the time from randomization to death from any cause.
Up to 36 months
Event-free survival (EFS)
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
Up to 36 months
Incidence of adverse events during the treatment and follow-up (safety)
Adverse events will be assessed during treatment and follow-up.
until 100 days after last patient last study drug treatment
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  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.

  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;
The First Affiliated Hospital of Zhengzhou University logoThe First Affiliated Hospital of Zhengzhou University
Study Responsible Party
Feng Wang, Principal Investigator, Head of the oncology ward, The First Affiliated Hospital of Zhengzhou University
No contact data.