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Organ Preservation With Tislelizumab and Total Neoadjuvant Therapy in Patients With Low Rectal Cancer: RELIEVE -01 Study
Sponsor: Fudan University
Summary
This is an open-label, multi-center, single-arm clinical study. All patients received concurrent chemoradiation therapy (CRT) followed by 4 cycles of tislelizumab combined with CAPOX, then underwent clinical response assessment. Patients who achieved CR (cCR+ pCR confirmed by local resection of ncCR) continue tislelizumab combined with CAPOX for another 4 cycles and tislelizumab for 9 cycles, then Watch and Wait. Patients who did not achieved CR underwent total mesorectal excision (TME).
Official title: A Single-arm, Multicenter, Phase II Clinical Study of Chemoradiotherapy Followed by Tislelizumab Combined With Chemotherapy for Organ Preservation in Resectable Low Rectal Cancer:the RELIEVE-01 Study
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
46
Start Date
2024-05
Completion Date
2028-12
Last Updated
2024-04-30
Healthy Volunteers
No
Conditions
Interventions
Radiotherapy
45-50.4Gy in 25-28 fractions to the pelvis on Days 1-5 every week.
Tislelizumab
200 mg IV on Day 1 of each 21-day cycle.
Capecitabine
Capecitabine 1000 mg/m2 orally twice daily (bid) on Day 1 to 14 of each 21-day cycle in CAPOX regimen
Oxaliplatin
130 mg/m2 IV on Day 1 of each 21-day cycle in CAPOX regimen
Capecitabine
825 mg/m2 orally twice daily (bid) 5 days/week during radiotherapy.