A Phase 3 interventional study of node-sparing modified short-course radiotherapy and standard short-course radiotherapy in Rectal Cancer, sponsored by Sir Run Run Shaw Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Sir Run Run Shaw Hospital · Phase 3, Interventional, and Treatment
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.
2,400 studies on the registry are indexed under Rectal Neoplasms; 587 are open to participants now.
This study's planned enrollment of 210 is above the median of 65 across 1,751 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Sir Run Run Shaw Hospital is the lead sponsor of 135 studies on the registry; 72 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Radiotherapy: 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.
Radiation: node-sparing modified short-course radiotherapy
standard 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.
Radiation: standard short-course radiotherapy
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.
Also known as: tislelizumab, 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.
Also known as: CAPOX
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.
Time frame: up to 5 years
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.
Time frame: Up to 6 months
Overall Survival (OS)
Overall survival (OS) is defined as the time interval from randomization to death from any cause.
Time frame: Up to 8 years
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.
Time frame: Up to 5 years
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.
Time frame: Up to 5 years
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.
Time frame: Up to 5 years
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.
Time frame: Up to 5 years
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.
Time frame: Up to 5 years
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.
Time frame: Up to 5 years
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.
Time frame: Up to 5 years
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.
Time frame: Up to 5 years
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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