Status:
RECRUITING
Maintenance Tislelizumab + Capecitabine to Treat Metastatic Colorectal Cancer
Lead Sponsor:
Yanhong Deng
Conditions:
Metastatic Colorectal Cancer，NED
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 o...
Detailed Description
This is a Phase 2, randomized, open-label, single-center study designed to compare the efficacy and safety of tislelizumab+ capecitabine versus best-supported care as a first-line maintenance treatmen...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Presence of any other active cancer
- Presence of active infections requiring antibiotics
- History of active autoimmune disease requiring systemic treatment
Key Trial Info
Start Date :
August 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2027
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT05360277
Start Date
August 22 2023
End Date
November 30 2027
Last Update
December 12 2023
Active Locations (1)
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1
Gastrointestinal Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510655