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

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

46

Participants

Timeline

Start Date

May 31, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2028

Conditions
RECTAL NEOPLASMSRectal Cancer
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.

All Listed Sponsors
collaborator

Shanghai Zhongshan Hospital

OTHER

collaborator

Shanghai Changzheng Hospital

OTHER

collaborator

Huadong Hospital

OTHER

collaborator

RenJi Hospital

OTHER

collaborator

Hebei Medical University Fourth Hospital

OTHER

collaborator

First Hospital of China Medical University

OTHER

collaborator

Liaoning Cancer Hospital & Institute

OTHER

lead

Fudan University

OTHER

NCT06390982 - Organ Preservation With Tislelizumab and Total Neoadjuvant Therapy in Patients With Low Rectal Cancer: RELIEVE -01 Study | Biotech Hunter | Biotech Hunter