NCT06390982

Organ Preservation With Tislelizumab and Total Neoadjuvant Therapy in Patients With Low Rectal Cancer: RELIEVE -01 Study

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• RECTAL NEOPLASMS
• Rectal Cancer

Interventions

Type	Name	Description
RADIATION	Radiotherapy	45-50.4Gy in 25-28 fractions to the pelvis on Days 1-5 every week.
DRUG	Tislelizumab	200 mg IV on Day 1 of each 21-day cycle.
DRUG	Capecitabine	Capecitabine 1000 mg/m2 orally twice daily (bid) on Day 1 to 14 of each 21-day cycle in CAPOX regimen
DRUG	Oxaliplatin	130 mg/m2 IV on Day 1 of each 21-day cycle in CAPOX regimen
DRUG	Capecitabine	825 mg/m2 orally twice daily (bid) 5 days/week during radiotherapy.

Timeline

• Start date: 2024-05-01
• Primary completion: 2025-12-01
• Completion: 2028-12-01
• First posted: 2024-04-30
• Last updated: 2024-04-30