Using Tislelizumab and Capecitabine for Maintenance in Metastatic Colorectal Cancer
Maintenance Tislelizumab Combined With Capecitabine to Treat Metastatic Colorectal Cancer With No Evidence of Disease
This study is testing if a combination of two drugs, tislelizumab and capecitabine, can help keep patients with metastatic colorectal cancer cancer-free after surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy, Tislelizumab |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05360277 on ClinicalTrials.gov |
What this trial studies
This Phase 2 clinical trial investigates the efficacy and safety of a combination of tislelizumab and capecitabine as a maintenance treatment for patients with metastatic colorectal cancer (mCRC) who have achieved no evidence of disease (NED) after surgery. Participants will be randomly assigned to receive either the combination treatment or best supportive care. The primary focus is on disease-free survival, while secondary outcomes include overall survival and the assessment of adverse events. This study aims to provide new insights into maintaining remission in mCRC patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 to 80 with histologically confirmed colorectal adenocarcinoma who have undergone surgery and achieved no evidence of disease.
Not a fit: Patients with other active cancers, active infections, or autoimmune diseases requiring systemic treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve disease-free survival for patients with metastatic colorectal cancer who have achieved no evidence of disease.
How similar studies have performed: While this approach is novel in the context of mCRC-NED, similar immunotherapy combinations have shown promise in other cancer types.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 20 years, \< 80 years 2. Written informed consent 3. Histologically or cytologically confirmed CRC 4. 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. 5. cytoreduction surgery achieves CC0 (no visible residual tumor) if there is peritoneal metastasis 6. No previous chemotherapy 7. Synchronous or metachronous metastatic disease: maximum of two distant organs or regions involved 8. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 9. Adequate hematologic and organ function Exclusion Criteria: 1. Presence of any other active cancer 2. Presence of active infections requiring antibiotics 3. History of active autoimmune disease requiring systemic treatment
Where this trial is running
Guangzhou, Guangdong
- Gastrointestinal Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.