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Tislelizumab for Resectable Ultra-low Rectal Cancer

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What is being tested

Long-course chemoradiotherapy

+ CAPOX regimen

+ Tislelizumab combined with the CAPOX regimen

RadiationDrug
Who is being recruted

Digestive System Diseases+8

+ Digestive System Neoplasms

+ Gastrointestinal Diseases

From 18 to 75 Years
+25 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: August 2025
See protocol details

Summary

Principal SponsorFudan University
Study ContactJianmin Xu, MDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2025

Actual date on which the first participant was enrolled.

This study focuses on treating patients with a type of rectal cancer called ultra-low rectal adenocarcinoma. It specifically targets individuals whose cancer is resectable, meaning it can potentially be removed by surgery, and who have not previously received treatment. The trial aims to explore the effectiveness of adding a drug called tislelizumab to the standard treatment of chemoradiotherapy followed by chemotherapy. Understanding whether tislelizumab can improve outcomes, such as preserving the anus and delaying or avoiding more invasive surgery, is crucial for enhancing the quality of life for patients with this challenging condition. Participants in the study receive a combination of chemotherapy and radiation therapy, and then some receive additional cycles of chemotherapy with or without tislelizumab. Treatment success is measured by how well the cancer responds, focusing on whether surgery can be avoided and how long patients remain cancer-free. Those who do not respond fully to the initial treatment are advised to undergo a surgery called total mesorectal excision. The study tracks various outcomes like how many people can keep their organ intact over one to three years and overall survival rates, providing important data on the potential benefits and risks of the treatment strategy.

Official TitleA Multicenter, Randomized Controlled Clinical Study of Concurrent Chemoradiotherapy Followed by Chemotherapy With or Without Tislelizumab for Resectable Ultra-low Rectal Cancer: The RELIEVE-02 Study
NCT07132463
Principal SponsorFudan University
Study ContactJianmin Xu, MDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

154 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsIntestinal DiseasesIntestinal NeoplasmsNeoplasmsNeoplasms by SiteRectal DiseasesRectal NeoplasmsColorectal Neoplasms

Criteria

11 inclusion criteria required to participate
Able to provide written informed consent, understand, and comply with the requirements and evaluation schedule.

Age ≥18 and ≤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.

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14 exclusion criteria prevent from participating
Histologically confirmed poorly differentiated/undifferentiated adenocarcinoma, mucinous adenocarcinoma, or signet ring cell carcinoma.

Previously received treatment for rectal cancer or have evidence of distant metastasis.

Presence of the following high-risk factors assessed by MRI: MRF+, EMVI+, cN2, positive lateral lymph nodes, T3d.

Presence of or at high risk for obstruction, perforation, or bleeding.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Long-course chemoradiotherapy followed by 4 cycles of CAPOX. (Note: Patients evaluated as ncCR after completion, if refusing local excision, may receive an additional 2 cycles of CAPOX before re-evaluation.)

Group II

Experimental
Long-course chemoradiotherapy followed by 4 cycles of CAPOX and Tislelizumab. (Note: Patients evaluated as ncCR after completion, if refusing local excision, may receive an additional 2 cycles of CAPOX and Tislelizumab before re-evaluation.)

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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