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NOT YET RECRUITING
NCT06390982
PHASE2

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

Sponsor: Fudan University

View on ClinicalTrials.gov

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

Interventions

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.