NCT07132463View on ClinicalTrials.gov

Neoadjuvant Chemoradiotherapy Followed by Chemotherapy With or Without Tislelizumab for Resectable Ultra-low Rectal Cancer: The RELIEVE-02 Study

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

154

Participants

Timeline

Start Date

August 31, 2025

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2030

Conditions
Rectal Cancer
Interventions
RADIATION

Long-course chemoradiotherapy

45-50.4 Gy in 25-28 fractions to the pelvis on Days 1-5 each week. Capecitabine at a dose of 825 mg/m², taken orally twice daily (bid), 5 days per week during radiotherapy.

DRUG

Tislelizumab combined with the CAPOX regimen

"Tislelizumab 200 mg IV on Day 1 of each 21-day cycle. Capecitabine: 1000 mg/m² orally twice daily (bid) on Days 1-14 of each 21-day cycle.~Oxaliplatin: 130 mg/m² IV on Day 1 of each 21-day cycle."

DRUG

CAPOX regimen

"Capecitabine: 1000 mg/m² orally twice daily (bid) on Days 1-14 of each 21-day cycle.~Oxaliplatin: 130 mg/m² IV on Day 1 of each 21-day cycle."

All Listed Sponsors
lead

Fudan University

OTHER