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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
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• 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

Locations
Other Locations
China
Gastrointestinal Hospital, Sun Yat-sen University
RECRUITING
Guangzhou
Time Frame
Start Date: 2023-08-22
Estimated Completion Date: 2027-11-30
Participants
Target number of participants: 52
Treatments
Experimental: Tislelizumab + Capecitabine
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.
Active_comparator: Best supportive care
Best supportive care was the standard care in this setting.
Related Therapeutic Areas
Sponsors
Leads: Yanhong Deng

This content was sourced from clinicaltrials.gov