NCT05360277RecruitingPhase 2
Maintenance Tislelizumab + Capecitabine to Treat Metastatic Colorectal Cancer
Maintenance Tislelizumab Combined With Capecitabine to Treat Metastatic Colorectal Cancer With No Evidence of Disease
Source: ClinicalTrials.gov · Last updated 12 Dec 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Surgery with integrated treatment for metastatic colorectal cancer (mCRC) has created a new clinical setting known as mCRC with no evidence of disease (NED). However, these patients have a high risk of developing persistent cancer. This study aimed to investigate the efficacy and safety of Tislelizumab combined with capecitabine as a maintenance treatment for patients with mCRC-NED.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 52 (estimated)
- First submitted
- 30 Apr 2022
- Start date
- Aug 2023
- Primary completion date
- Feb 2025
- Lead sponsor
- Yanhong Deng
- Diseases
- Colorectal cancer
- NCT number
- NCT05360277
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 52
- From Aug 2023 to the primary completion date, Feb 2025
- 1 site in 1 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, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Presence of any other active cancer
- Presence of active infections requiring antibiotics
- History of active autoimmune disease requiring systemic treatment
Who the study is looking for
- Age ≥ 20 years, \< 80 years
- Written informed consent
- Histologically or cytologically confirmed CRC
- Surgery with integrated treatment for metastatic colorectal cancer (mCRC) and achieved a statute of no evidence of disease (NED), as determined by a multidisciplinary tumor board.
- cytoreduction surgery achieves CC0 (no visible residual tumor) if there is peritoneal metastasis
- No previous chemotherapy
- Synchronous or metachronous metastatic disease: maximum of two distant organs or regions involved
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Adequate hematologic and organ function
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gastrointestinal Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.