Maintenance Tislelizumab + Capecitabine to Treat Metastatic Colorectal Cancer
Recruiting · NCT05360277 · Interventional (participants receive a specific treatment) · Lead sponsor: Yanhong Deng
View the official record on ClinicalTrials.gov →Interventions studied
Best supportive careTislelizumab + Capecitabine
What this trial is about
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.
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- Presence of any other active cancer
- Presence of active infections requiring antibiotics
- History of active autoimmune disease requiring systemic treatment
Where it is running
1 location listed.
- Gastrointestinal Hospital, Sun Yat-sen University - Guangzhou, Guangdong, China