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RECTAL NEOPLASMSPhase 2NCT06390982

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

A Phase 2 study testing Radiotherapy, Tislelizumab and Capecitabine in people with RECTAL NEOPLASMS and Rectal Cancer, run by Fudan University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
RECTAL NEOPLASMS, Rectal Cancer
What is being tested?
Radiotherapy, Tislelizumab and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
No sites listed yet
Study dates
May 2024to Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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.

Who cannot join

  • 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
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  • ≥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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Min Jian Xu, MD contact

86-21-64041990

xujmin@aliyun.com

Tao Wen Tang, MD contact

Tangwt1988@163.com

About this study

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

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).

Being tested
Radiotherapy, Tislelizumab, Capecitabine, Oxaliplatin
Keywords
tislelizumab, low rectal cancer, organ preservation, watch and wait, TNT
Medical subject headings
Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RadiotherapyRadiation

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

  • TislelizumabDrug

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

  • CapecitabineDrug

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

  • OxaliplatinDrug

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

  • CapecitabineDrug

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

Study groups in NCT06390982
Study groupRoleWhat they receive
tislelizumabExperimentalCRT followed by 4 cycles of tislelizumab plus CAPOX and clinical response assessment: participants with CR (cCR+ pCR confirmed by local resection of ncCR): another 4 cycles of tislelizumab plus CAPOX and 9 cycles of tislelizumab, then watch and wait. participants with non-CR: underwent TME
Receives: Radiation: Radiotherapy; Drug: Tislelizumab; Drug: Capecitabine; Drug: Oxaliplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From first dose up to 12 months, approximately

Secondary outcomes (4)

  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)

    Measured: 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)

    Measured: 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)

    Measured: 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

    Measured: From first dose of radiotherapy up to 36 months, approximately

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2024
  2. Study startMay 2024 (estimated)
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06390982
Sponsor's protocol ID
BGB-A317-2011-IIT
Status last verified
Apr 2024
First submitted
26 Apr 2024
Last updated
30 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Radiotherapy, Tislelizumab and Capecitabine in people with RECTAL NEOPLASMS and Rectal Cancer, run by Fudan University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Min Jian Xu, MD (86-21-64041990, xujmin@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete Response rate (CR rate) (time frame: From first dose up to 12 months, approximately). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06390982.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.

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