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Not yet recruiting NCT06390982

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

Phase II Interventional RECTAL NEOPLASMS Rectal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Radiotherapy, Tislelizumab, Capecitabine, Oxaliplatin.
Who it may be relevant to
Registry conditions: RECTAL NEOPLASMS, Rectal Cancer. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Single-arm, Multicenter, Phase II Clinical Study of Chemoradiotherapy Followed by Tislelizumab Combined With Chemotherapy for Organ Preservation in Resectable Low Rectal Cancer：the RELIEVE-01 Study

Overview

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).

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.

Primary outcome measures

  • Complete Response rate (CR rate) [Time frame: From first dose up to 12 months, approximately]
Secondary outcome measures (4)
  • 1/2/3 year organ-preservation rate [Time frame: From first dose of radiotherapy up to 36 months, approximately]
  • 1/2/3 year EFS rate [Time frame: From first dose of radiotherapy up to 36 months, approximately]
  • 1/2/3 year OS rate [Time frame: From first dose of radiotherapy up to 36 months, approximately]
  • Percentage of Participants With Adverse Events [Time frame: From first dose of radiotherapy up to 36 months, approximately]

Eligibility criteria

Inclusion criteria

  • 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
  • The distance from the lower edge of the tumor to the anal verge is ≤5 cm through colonoscopy, digital anal examination or MRI
  • clinical stage cT1-3N1M0 or cT2-3N0M0 (the 8th UICC/AJCC; T and N is evaluated by MRI)
  • Resectable primary tumor assessed by the Investigator
  • Have not received any anti-tumor treatment for rectal cancer
  • ECOG PS ≤ 1
  • Adequate organ function
  • Female subjects with the ability to become pregnant must have a serum pregnancy test with a negative result within 72 hours before the first dose, and be willing to use highly effective contraceptive methods during the trial and 120 days after the last dose. Male subjects whose partners are women of childbearing potential should be surgically sterilized or agree to use a highly effective method of contraception during the trial and for 120 days after the last dose.

Exclusion criteria

  • 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;
  • Not suitable for long-course radiotherapy
  • Cannot tolerate surgery
  • ≥2 colorectal cancer lesions at the same time
  • Contraindications for MRI examination
  • Other malignant tumors in the past or at the same time
  • Have an active autoimmune disease requiring systemic therapy within the past 2 years
  • HIV infection
  • Untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers (HBV DNA \> 500 IU/mL) or active HCV carriers with detectable HCV RNA;
  • Hypersensitivity to any ingredient of tislelizumab, capecitabine, and oxaliplatin or to any component of the container
  • Other conditions judged by the researcher that do not meet the enrollment requirements

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06390982 · BGB-A317-2011-IIT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗