Maintenance Tislelizumab + Capecitabine to Treat Metastatic Colorectal Cancer

Recruiting now · Phase 2

Conditions studied: Metastatic Colorectal Cancer，NED

In brief

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.

Key facts

Study ID

NCT05360277

Run by

Yanhong Deng

People needed

52

Starts

2023-08-22

Expected to finish

2027-11-30

Last updated by the study team

2023-12-12

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Presence of any other active cancer
• Presence of active infections requiring antibiotics
• History of active autoimmune disease requiring systemic treatment

Where it is running

• Gastrointestinal Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.