NCT05841134Not yet recruitingPhase 2
Tislelizumab Combined With Chemotherapy (CAPOX) in the Perioperative Treatment of MSI-H/dMMR Stage II or III Colorectal Cancer
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
Source: ClinicalTrials.gov · Last updated 9 May 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- First submitted
- 23 Apr 2023
- Start date
- 1 Jun 2023
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou University
- Diseases
- Colorectal cancer
- NCT number
- NCT05841134
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 25
- From 1 Jun 2023 to the primary completion date, 31 Dec 2024
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have received anti-tumor therapy;
- Have received PD-(L)1 or CTLA-4 treatment;
- 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;
Other illness
- 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 with any severe and/or uncontrolled diseases
- 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;
Other
- Urine routine prompts urine protein ≥ ++, and confirmed 24-hour urine protein quantity \> 1.0g;
- Pregnant or lactating women;
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.