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

NCT06390982 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2024-04-30

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    collaborator OTHER

  • Shanghai Changzheng Hospital

    collaborator OTHER

  • Huadong Hospital

    collaborator OTHER

  • RenJi Hospital

    collaborator OTHER

  • Hebei Medical University Fourth Hospital

    collaborator OTHER

  • First Hospital of China Medical University

    collaborator OTHER

  • Liaoning Cancer Hospital & Institute

    collaborator OTHER

  • Fudan University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-31
Primary Completion
2025-12-31
Completion
2028-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06390982 on ClinicalTrials.gov