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Rectal CancerPhase 3mRCATSNCT07900061

Modified Short-Course Radiotherapy Combined With Tislelizumab and CAPOX for pMMR/MSS Rectal Cancer

A Phase 3 study testing node-sparing modified short-course radiotherapy and standard short-course radiotherapy in people with Rectal Cancer, run by Sir Run Run Shaw Hospital.

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

The goal of this clinical trial is to learn if node-sparing modified short-course radiotherapy combined with tislelizumab and CAPOX works to treat pMMR/MSS locally advanced mid-to-low rectal cancer. It will also learn about the safety of this treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rectal Cancer
What is being tested?
node-sparing modified short-course radiotherapy and standard short-course radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
210 participants
Where
No sites listed yet
Study dates
25 Oct 2026to Dec 2034
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Participants aged 18 years or older, regardless of gender.
  • 2. Tumor located in the rectum, ≤10 cm from the anal verge.
  • 3. Histologically confirmed adenocarcinoma, with pMMR by immunohistochemistry or MSS by genetic testing.
  • 4. Clinical stage cT3-4N0/+M0.
  • 5. ECOG PS 0-1.
  • 6. Adequate function of major organs and bone marrow.
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  • 7. No contraindications to surgery.
  • 8. Good compliance and willingness to complete subsequent follow-up.
  • 9. Voluntary participation in this study and signed informed consent form.

Who cannot join

  • 1. Prior use of PD-1, PD-L1 or other immune checkpoint inhibitors.
  • 2. Prior receipt of any anti-tumor therapy for colorectal cancer, including radiotherapy, chemotherapy, or tumor resection.
  • 3. Microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR).
  • 4. Presence of peritoneal metastasis or metastasis to other distant organs.
  • 5. Participation in another anti-tumor investigational drug clinical trial within 4 weeks prior to enrollment.
  • 6. History of hypersensitivity to any components of monoclonal antibodies, tislelizumab, capecitabine, or oxaliplatin.
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  • 7. Confirmed immunodeficiency disease or active autoimmune disease, including but not limited to systemic lupus erythematosus, inflammatory bowel disease, myasthenia gravis, autoimmune hepatitis, rheumatoid arthritis, multiple sclerosis, glomerulonephritis, vasculitis, etc.; use of other immunosuppressants or systemic corticosteroids for immunosuppressive purposes within 4 weeks prior to enrollment.
  • 8. Known human immunodeficiency virus (HIV) infection; known clinically significant liver disease, including viral hepatitis [active HBV infection (HBV DNA ≥2000 IU/mL or 10⁴ copies/mL), hepatitis C (positive anti-HCV antibody with HCV RNA above the assay lower limit of detection)].
  • 9. Diseases associated with high bleeding risk such as gastrointestinal hemorrhage, bleeding diathesis, or thromboembolic diseases requiring long-term oral anticoagulants or anti-platelet agents.
  • 10. Uncontrolled cardiac clinical signs or diseases, including but not limited to: a) NYHA class II or higher heart failure; b) unstable angina; c) myocardial infarction within the past 1 year; d) clinically significant supra-ventricular or ventricular arrhythmia that is untreated or poorly controlled after clinical intervention.
  • 11. Severe infection (CTCAE grade >2) within 4 weeks prior to the first dose of study drug, such as severe pneumonia requiring hospitalization, bacteremia, infectious complications, etc.; active pulmonary inflammation indicated on baseline chest imaging; active tuberculosis infection identified by medical history or CT scan, history of active tuberculosis within 1 year before enrollment, or history of active tuberculosis >1 year previously without adequate treatment.
  • 12. Diagnosis of another malignancy within 5 years before the first dose of study drug, except for malignancies with low risk of metastasis or death (5-year survival rate >90%), such as adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.
  • 13. Pregnant or lactating women.
  • 14. Vulnerable populations other than the elderly or illiterate subjects, including patients with psychiatric disorders, cognitive impairment, critically ill patients, etc.
  • 15. Other conditions that, in the investigator's judgment, may force premature termination of study participation.

Trial locations and contacts

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

Zhentian Xu, MD contact

8657186006811

xztzd@zju.edu.cn

About this study

Official title: Modified Short-Course Radiotherapy Combined With Tislelizumab and CAPOX for pMMR/MSS Locally Advanced Mid-to-low Rectal Cancer: An Open-label, Multi-center, Randomized Controlled Trial

The goal of this clinical trial is to learn if node-sparing modified short-course radiotherapy combined with tislelizumab and CAPOX works to treat pMMR/MSS locally advanced mid-to-low rectal cancer. It will also learn about the safety of this treatment. The main question it aims to answer is: Does node-sparing modified short-course radiotherapy combined with tislelizumab and CAPOX prolong survival and improve the quality of life of participants? Researchers will compare node-sparing modified short-course radiotherapy combined with tislelizumab and CAPOX to standard short-course radiotherapy combined with CAPOX to see if it works to treat pMMR/MSS locally advanced mid-to-low rectal cancer. Participants will randomized allocated to accept one of the two treatments. After 4 cycles chemotherapy plus tislelizumab or not, participants will be managed with total mesorectal excision (TME), local excision, or a watch-and-wait strategy based on their clinical response and will undergo long-term follow-up.

Conditions
Rectal Cancer
Being tested
node-sparing modified short-course radiotherapy, standard short-course radiotherapy
Medical subject headings
Rectal Neoplasms

What participants receive

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

  • node-sparing modified short-course radiotherapyRadiation

    Also called tislelizumab, CAPOX

    Study participants receive modified short-course radiotherapy to the rectum for 5 days. The radiation field covers the primary rectal tumor region, excluding regional lymphatic drainage areas, with a total radiation dose of 25 Gy (5 Gy per fraction × 5 fractions). On Day 8 after radiotherapy initiation, participants receive combination therapy with CAPOX (Oxaliplatin 130 mg/m², ivgtt on Day 1; Capecitabine 1000 mg/m², bid po from Day 1 to Day 14; q3w) and tislelizumab (200 mg, ivgtt on Day 1; q3w). Treatment cycles are repeated every 3 weeks for a total of 4 cycles.

  • standard short-course radiotherapyRadiation

    Also called CAPOX

    Study participants receive standard short-course radiotherapy for 5 days. On Day 8 after radiotherapy initiation, participants receive CAPOX (Oxaliplatin 130 mg/m², ivgtt on Day 1; Capecitabine 1000 mg/m², bid po from Day 1 to Day 14; q3w). Treatment cycles are repeated every 3 weeks for a total of 4 cycles.

Study groups in NCT07900061
Study groupRoleWhat they receive
node-sparing modified short course radiotherapy combined with tislelizumab and CAPOXExperimentalRadiotherapy: modified short-course radiotherapy for 5 days. CAPOX: Oxaliplatin 130 mg/m², once ivgtt on Day 1; Capecitabine 1000 mg/m², bid po from Day 1 to Day 14; q3w. Tislelizumab: 200 mg, ivgtt on Day 1; q3w. Treatment cycles are repeated every 3 weeks for a total of 4 cycles.
Receives: Radiation: node-sparing modified short-course radiotherapy
standard short course radiotherapy combined with CAPOXActive comparatorstandard short-course radiotherapy for 5 days. CAPOX: Oxaliplatin 130 mg/m², once ivgtt on Day 1; Capecitabine 1000 mg/m², bid po from Day 1 to Day 14; q3w. Treatment cycles are repeated every 3 weeks for a total of 4 cycles.
Receives: Radiation: standard short-course radiotherapy

What is being measured

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

  1. Disease Free Survival (DFS)

    Time from randomization to the first occurrence of locoregional recurrence, distant metastasis, new invasive primary colorectal carcinoma or death from any cause, whichever occurs first.

    Measured: up to 5 years

Secondary outcomes (10)

  1. Complete Response (CR) rate

    The complete response (CR) rate is defined as the proportion of subjects achieving a complete response including clinical complete response accepting watch and wait strategy and pathological complete response who underwent the surgery.

    Measured: Up to 6 months

  2. Overall Survival (OS)

    Overall survival (OS) is defined as the time interval from randomization to death from any cause.

    Measured: Up to 8 years

  3. Organ Preservation Rate (OPR)

    Organ preservation rate (OPR) is defined as the proportion of participants with successful organ preservation at the pre-specified time point from randomization. Organ preservation is regarded as failure if any of the following occurs: 1) performance of definitive total mesorectal excision (TME); 2) development of unresectable locoregional tumor regrowth or recurrence; 3) creation of permanent stoma. Local excision is not considered definitive radical resection.

    Measured: Up to 5 years

  4. Locoregional Control Rate (LCR)

    Locoregional control rate (LCR) is defined as the proportion of subjects without locoregional failure from randomization up to the prespecified time point. Locoregional failure is defined as the first documented occurrence of primary rectal tumor regrowth or pelvic regional nodal recurrence. Isolated distant metastasis alone shall not be regarded as locoregional failure.

    Measured: Up to 5 years

  5. Locoregional Recurrence Free Survival (LRFS)

    Locoregional recurrence free survival (LRFS) is defined as the time interval from randomization to the first documented locoregional failure. Locoregional failure is defined as the first documented occurrence of primary rectal tumor regrowth or pelvic regional nodal recurrence.

    Measured: Up to 5 years

  6. Distant Metastasis-Free Survival (DMFS)

    Distant metastasis free survival (DMFS) is defined as the time interval from randomization to the first documented distant metastatic event. Distant metastatic event is defined as the first documented distant metastasis outside the pelvis.

    Measured: Up to 5 years

  7. Adverse Event (AE)

    Any untoward medical occurrence temporally associated with study treatment, whether or not related to the study intervention. The incidence rates of adverse events will be calculated and compared between the two treatment groups.

    Measured: Up to 5 years

  8. Quality of life (QoL) assessment via EORTC QLQ-C30

    European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3.0. This is a validated patient-reported questionnaire for cancer patients. The scale score ranges from 0 to 100. Higher scores indicate better global health status and quality of life.

    Measured: Up to 5 years

  9. Quality of life (QoL) assessment via EORTC QLQ-CR29.

    European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC QLQ-CR29). The scale score ranges from 0 to 100. Higher scores indicate better body image but more severe blood and mucus in stool and more severe stoma care problems.

    Measured: Up to 5 years

  10. Quality of life (QoL) assessment via Wexner Score

    Cleveland Clinic Florida Fecal Incontinence Score (Wexner Score). A validated patient-reported scale to assess the severity of fecal incontinence. The total score ranges from 0 to 20. Higher scores indicate more severe fecal incontinence.

    Measured: Up to 5 years

Timeline

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

  1. First posted28 Oct 2026
  2. Study start25 Oct 2026 (estimated)
  3. Primary completionDec 2031 (estimated)
  4. Study completionDec 2034 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
210 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07900061
Sponsor's protocol ID
SRRSH-mRCATS-2026-01
Acronym
mRCATS
Status last verified
Oct 2026
First submitted
16 Oct 2026
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing node-sparing modified short-course radiotherapy and standard short-course radiotherapy in people with Rectal Cancer, run by Sir Run Run Shaw Hospital.

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 9 inclusion and 15 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 28 Oct 2026. 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 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 Zhentian Xu, MD (8657186006811, xztzd@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease Free Survival (DFS) (time frame: up to 5 years). 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 NCT07900061.

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 28 Oct 2026.

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