RECRUITINGPhase 2INTERVENTIONAL

Maintenance Tislelizumab + Capecitabine to Treat Metastatic Colorectal Cancer

Maintenance Tislelizumab Combined With Capecitabine to Treat Metastatic Colorectal Cancer With No Evidence of Disease

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: 1. Age ≥ 20 years, \< 80 years 2. Written willing to sign a consent form 3. diagnosed by tissue sample (biopsy-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 Who Should NOT Join This Trial: 1. Presence of any other active cancer 2. Presence of active infections requiring antibiotics 3. History of active autoimmune conditions (where your immune system attacks your own body) requiring systemic treatment Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

Tislelizumab + Capecitabine

Tislelizumab 200mg iv every 3 weeks, for 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.

OTHER

Best supportive care

Locations (1)

Gastrointestinal Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China