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

ConditionsRECTAL NEOPLASMSRectal Cancer
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Radiotherapy

    Radiation

    45-50.4Gy in 25-28 fractions to the pelvis on Days 1-5 every week.

  • Tislelizumab

    Drug

    200 mg IV on Day 1 of each 21-day cycle.

  • Capecitabine

    Drug

    Capecitabine 1000 mg/m2 orally twice daily (bid) on Day 1 to 14 of each 21-day cycle in CAPOX regimen

  • Oxaliplatin

    Drug

    130 mg/m2 IV on Day 1 of each 21-day cycle in CAPOX regimen

  • Capecitabine

    Drug

    825 mg/m2 orally twice daily (bid) 5 days/week during radiotherapy.

Treatment groups

46 Participants
are divided into 1 treatment group
Group A: tislelizumabExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Complete Response rate (CR rate)

defined as the proportion of participants with clinical complete response(cCR) or near clinical complete response (ncCR) who achieved local resection confirmed pCR determined by the investigators after CRT and 4 cycles of CAPOX plus tislelizumab.

Time frame
From first dose up to 12 months, approximately

Secondary outcomes

1

1/2/3 year organ-preservation rate

defined as the proportion of participants who survived and did not underwent TME in 1/2/3 year (in the CR set and full analysis set respectively)

Time frame
From first dose of radiotherapy up to 36 months, approximately
2

1/2/3 year EFS rate

defined as the proportion of participants who did not develop local recurrence, distant metastasis, new invasive primary lesions of colorectal cancer, or death in 1/2/3 year (in the CR set, non-CR set and full analysis set respectively)

Time frame
From first dose of radiotherapy up to 36 months, approximately
3

1/2/3 year OS rate

defined as the proportion of participants who survived in 1/2/3 year (in the full analysis set)

Time frame
From first dose of radiotherapy up to 36 months, approximately
4

Percentage of Participants With Adverse Events

Percentage of Participants With adverse events (AEs) , immune-related adverse events(irAE) and serious adverse events (SAEs) per the National Cancer Institute CommonTerminology Criteria for Adverse Events (NCI CTCAE) Version 5.0

Time frame
From first dose of radiotherapy up to 36 months, approximately

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Source ClinicalTrials.gov

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