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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFudan University

About this trial

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).

Eligibility criteria

Qualifiers

Able to provide written informed consent, understand and comply with the requirements and evaluation schedule

≥18, ≤75 years old

Histologically confirmed rectal adenocarcinoma

immunohistochemistry confirmed pMMR (positive for MLH1, MSH2, MSH6 and PMS2), or PCR /NGS confirmed MSI-L or MSS

Disqualifiers

Histologically confirmed poorly differentiated/undifferentiated adenocarcinoma, mucinous adenocarcinoma and signet ring cell carcinoma

Have received any treatments for rectal cancer, or evidence of distant metastasis

Presence of following high risk factors assessed by MRI: MRF +, EMVI+, cN2, Positive lateral lymph nodes, T3d

Presence or in high risk of obstruction, perforation or bleeding;

Trial design

Treatments tested in this trial

  • Radiotherapy
  • Tislelizumab
  • Capecitabine
  • Oxaliplatin
  • Capecitabine

Treatment groups

46 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

Fudan University

Lead sponsor

Shanghai Zhongshan Hospital

Sponsor institution

Shanghai Zhongshan Hospital

Collaborator

Shanghai Changzheng Hospital

Collaborator

Huadong Hospital

Collaborator

RenJi Hospital

Collaborator

Hebei Medical University Fourth Hospital

Collaborator

First Hospital of China Medical University

Collaborator

Liaoning Cancer Hospital & Institute

Collaborator