drugset / Trial / NCT06390982
Organ Preservation With Tislelizumab and Total Neoadjuvant Therapy in Patients With Low Rectal Cancer: RELIEVE -01 Study
Phase 2
Not yet recruiting
46 enrolled
Fudan University
First Hospital of China Medical University · collabHebei Medical University Fourth Hospital · collabHuadong Hospital · collabLiaoning Cancer Hospital & Institute · collabRenJi Hospital · collabShanghai Changzheng Hospital · collabShanghai Zhongshan Hospital · collab
NaSingle-groupOpen-labelTreatment
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).
Timeline
- Start
- 2024-05
- Primary completion
- 2025-12
- Completion
- 2028-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 825 mg/m2 | Oral |
| Subject | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Subject | Oxaliplatin | Small molecule | 130 mg/m2 | Intravenous |
| Subject | Tislelizumab | Monoclonal antibody | 200 mg | Intravenous |