Clinical trial · Interventional
Maintenance Tislelizumab + Capecitabine to Treat Metastatic Colorectal Cancer
Maintenance Tislelizumab Combined With Capecitabine to Treat Metastatic Colorectal Cancer With No Evidence of Disease
NCT05360277CI-TRIAL-00072157CAMCO2recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Cancer，NED | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Best supportive care | Other | — | UNRESOLVED |
| Tislelizumab + Capecitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Tislelizumab + Capecitabine
- description
- Tislelizumab 200mg every 3 weeks, or 1 year after completion of perioperative chemotherapy. Capecitabine was given at a dose of 850 mg/m2 twice a day by mouth, 2 weeks on/ 1 week off, for 1 year after completion of perioperative chemotherapy.
- interventionNames
- Drug: Tislelizumab + Capecitabine
- type
- ACTIVE_COMPARATOR
- label
- Best supportive care
- description
- Best supportive care was the standard care in this setting.
- interventionNames
- Other: Best supportive care
Primary outcomes (1)
- measure
- Disease-free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.