Rectal CancerPhase 3NCT07132463
Neoadjuvant Chemoradiotherapy Followed by Chemotherapy With or Without Tislelizumab for Resectable Ultra-low Rectal Cancer: The RELIEVE-02 Study
A Phase 3 study testing Long-course chemoradiotherapy, Tislelizumab combined with the CAPOX regimen and CAPOX regimen in people with Rectal Cancer, run by Fudan University at 1 site in China.
Trial summary
This open-label, multicenter, randomized controlled trial involved 196 patients with pathologically confirmed, previously untreated, resectable MSI-L or MSS/pMMR ultra-low rectal adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Long-course chemoradiotherapy, Tislelizumab combined with the CAPOX regimen and CAPOX regimen
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteChina
- Study dates
- 12 Aug 2025to Dec 2030
- Phase
- Phase 3
- 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.
- 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.
- Tumor distal margin confirmed to be ≤ 3 cm from the anal verge by colonoscopy, digital rectal examination, or MRI.
- Clinical stage cT1-3N1M0 or cT3N0M0 (the 8th UICC/AJCC; T and N evaluated by MRI).
Show all 11Show fewer
- Resectable primary tumor assessed by the Investigator.
- No prior anti-tumor treatment for rectal cancer.
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 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 for 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, 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.
- Unsuitability for long-course radiotherapy.
- Inability to tolerate surgery.
Show all 14Show fewer
- ≥ 2 colorectal cancer lesions at the same time.
- Contraindications for MRI examination.
- Other malignant tumors in the past or currently present.
- 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 their containers.
- Other conditions judged by the researcher as not meeting the enrollment requirements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Wentao Tang, MD contact
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai
Wentao Tang, MD, +86 021-64041990, tangwt1988@163.com
About this study
Official title: A 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
This open-label, multicenter, randomized controlled trial involved 196 patients with pathologically confirmed, previously untreated, resectable MSI-L or MSS/pMMR ultra-low rectal adenocarcinoma. Patients were randomly assigned (1:1) to two groups to receive concurrent chemoradiotherapy followed by 4-6 cycles of chemotherapy ± tislelizumab. After treatment, patients who achieved complete clinical response (cCR), including those who reached pCR after local excision, or near cCR with pCR after local excision, were recommended to continue with 4-2 cycles of chemotherapy ± tislelizumab, followed by a watch-and-wait approach. Patients evaluated as incomplete responders were recommended for total mesorectal excision (TME) surgery. The primary endpoint is the anus preservation rate, while secondary endpoints include CR rate, 1-year/2-year/3-year organ preservation rates, 1-year/2-year/3-year EFS rates, and 1-year/2-year/3-year OS rates, etc.
- Conditions
- Rectal Cancer
- Being tested
- Long-course chemoradiotherapy, Tislelizumab combined with the CAPOX regimen, CAPOX regimen
- Keywords
- Ultra-low Rectal Cancer, Tislelizumab, Neoadjuvant Chemoradiotherapy, Anus Preservation, PD-1
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long-course chemoradiotherapyRadiation
45-50.4 Gy in 25-28 fractions to the pelvis on Days 1-5 each week. Capecitabine at a dose of 825 mg/m², taken orally twice daily (bid), 5 days per week during radiotherapy.
Tislelizumab combined with the CAPOX regimenDrug
Tislelizumab 200 mg IV on Day 1 of each 21-day cycle. Capecitabine: 1000 mg/m² orally twice daily (bid) on Days 1-14 of each 21-day cycle.
Oxaliplatin: 130 mg/m² IV on Day 1 of each 21-day cycle.
CAPOX regimenDrug
Capecitabine: 1000 mg/m² orally twice daily (bid) on Days 1-14 of each 21-day cycle.
Oxaliplatin: 130 mg/m² IV on Day 1 of each 21-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Concurrent Chemoradiotherapy Followed by Chemotherapy Plus Immunotherapy Group | 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.) Receives: Radiation: Long-course chemoradiotherapy; Drug: Tislelizumab combined with the CAPOX regimen |
| Concurrent Chemoradiotherapy Followed by Chemotherapy Group | 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.) Receives: Radiation: Long-course chemoradiotherapy; Drug: CAPOX regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anus preservation rate
Defined as the anus preservation rate in the efficacy-evaluable analysis set of patients, as assessed by the investigators.
Measured: From first dose of radiotherapy up to approximately 24/32±4 weeks.
Secondary outcomes (5)
Complete Response rate (CR Rate)
Defined as the proportion of participants with clinical complete response (cCR) and pathologic complete response (pCR), determined by the investigators.
Measured: From first dose of radiotherapy up to approximately 24/32±4 weeks.
1/2/3-Year Organ-Preservation Rate
Defined as the proportion of participants who survived and did not undergo TME at 1, 2, and 3 years.
Measured: From first dose of radiotherapy up to approximately 36 months.
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 at 1, 2, and 3 years.
Measured: From first dose of radiotherapy up to approximately 36 months.
1/2/3-Year OS Rate
Defined as the proportion of participants who survived at 1, 2, and 3 years.
Measured: From first dose of radiotherapy up to approximately 36 months.
Percentage of Participants With Adverse Events
Percentage of participants with adverse events (AEs), immune-related adverse events(irAE), and serious adverse events (SAEs).
Measured: From first dose of radiotherapy up to approximately 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start12 Aug 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu jianmin, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07132463
- Sponsor's protocol ID
- RELIEVE-02
- Status last verified
- Sep 2026
- First submitted
- 12 Aug 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 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
- ClinicalTrials.gov ID
- NCT07132463
- Acronym / sponsor ID
- RELIEVE-02
- Conditions
- Rectal Cancer
- Keywords
- Ultra-low Rectal Cancer, Tislelizumab, Neoadjuvant Chemoradiotherapy, Anus Preservation, PD-1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 12 Aug 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 20 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This open-label, multicenter, randomized controlled trial involved 196 patients with pathologically confirmed, previously untreated, resectable MSI-L or MSS/pMMR ultra-low rectal adenocarcinoma. Patients were randomly assigned (1:1) to two groups to receive concurrent chemoradiotherapy followed by 4-6 cycles of chemotherapy ± tislelizumab. After treatment, patients who achieved complete clinical response (cCR), including those who reached pCR after local excision, or near cCR with pCR after local excision, were recommended to continue with 4-2 cycles of chemotherapy ± tislelizumab, followed by a watch-and-wait approach. Patients evaluated as incomplete responders were recommended for total mesorectal excision (TME) surgery. The primary endpoint is the anus preservation rate, while secondary endpoints include CR rate, 1-year/2-year/3-year organ preservation rates, 1-year/2-year/3-year EFS rates, and 1-year/2-year/3-year OS rates, etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concurrent Chemoradiotherapy Followed by Chemotherapy Plus Immunotherapy Group | Experimental | Radiation: Long-course chemoradiotherapy, Drug: Tislelizumab combined with the CAPOX regimenLong-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.) |
| Concurrent Chemoradiotherapy Followed by Chemotherapy Group | Active comparator | Radiation: Long-course chemoradiotherapy, Drug: CAPOX regimenLong-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.) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
- Tumor distal margin confirmed to be ≤ 3 cm from the anal verge by colonoscopy, digital rectal examination, or MRI.
Key exclusion criteria (14 listed)
- 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.
- Unsuitability for long-course radiotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Long-course chemoradiotherapy45-50.4 Gy in 25-28 fractions to the pelvis on Days 1-5 each week. Capecitabine at a dose of 825 mg/m², taken orally twice daily (bid), 5 days per week during radiotherapy. | Radiation | Concurrent Chemoradiotherapy Followed by Chemotherapy Group, Concurrent Chemoradiotherapy Followed by Chemotherapy Plus Immunotherapy Group |
| Tislelizumab combined with the CAPOX regimenTislelizumab 200 mg IV on Day 1 of each 21-day cycle. Capecitabine: 1000 mg/m² orally twice daily (bid) on Days 1-14 of each 21-day cycle. Oxaliplatin: 130 mg/m² IV on Day 1 of each 21-day cycle. | Drug | Concurrent Chemoradiotherapy Followed by Chemotherapy Plus Immunotherapy Group |
| CAPOX regimenCapecitabine: 1000 mg/m² orally twice daily (bid) on Days 1-14 of each 21-day cycle. Oxaliplatin: 130 mg/m² IV on Day 1 of each 21-day cycle. | Drug | Concurrent Chemoradiotherapy Followed by Chemotherapy Group |
Primary outcome
Anus preservation rate
Time frame: From first dose of radiotherapy up to approximately 24/32±4 weeks.
Defined as the anus preservation rate in the efficacy-evaluable analysis set of patients, as assessed by the investigators.
5 secondary outcomes
Complete Response rate (CR Rate)
Time frame: From first dose of radiotherapy up to approximately 24/32±4 weeks.
1/2/3-Year Organ-Preservation Rate
Time frame: From first dose of radiotherapy up to approximately 36 months.
1/2/3-Year EFS Rate
Time frame: From first dose of radiotherapy up to approximately 36 months.
1/2/3-Year OS Rate
Time frame: From first dose of radiotherapy up to approximately 36 months.
Percentage of Participants With Adverse Events
Time frame: From first dose of radiotherapy up to approximately 36 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
Related trials for Rectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wentao Tang, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Long-course chemoradiotherapy, Tislelizumab combined with the CAPOX regimen and CAPOX regimen in people with Rectal Cancer, run by Fudan University at 1 site in China.
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: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Jianmin 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?
Anus preservation rate (time frame: From first dose of radiotherapy up to approximately 24/32±4 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Sep 2026.