Rectal CancerPhase 3mRCAT-IIINCT06507371
Node-sparing Short-Course Radiation Combined With CAPOX and Tislelizumab for MSS Rectal Cancer
A Phase 3 study testing node-sparing modified short-course radiotherapy, PD-1 antibody and Capecitabine in people with Rectal Cancer, run by Sir Run Run Shaw Hospital at 1 site in China.
Trial summary
This is a randomized, prospective, multicenter, open-label, Phase III clinical trial to evaluate node-sparing modified short-course radiation (Radiation targeting the tumor bed without irradiating surrounding tumor-draining lymph nodes) combined with CAPOX and PD-1 Inhibitor (Tislelizumab) compared with standard… 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?
- node-sparing modified short-course radiotherapy, PD-1 antibody and Capecitabine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteChina
- Study dates
- 29 Jul 2024to 30 Dec 2028
- 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
- Patients who have a strong willingness to preserve the anus and are willing to receive neoadjuvant therapy.
- Male or Female aged 18-75.
- Patients diagnosed with low rectal cancer within 10 cm from the lower edge of the tumor to the anal verge by pelvic MRI and anorectoscopy, the clinical stage is cT3-4bN0/+M0, and the lymph nodes are limited to the mesorectum.
- Histologically confirmed rectal adenocarcinoma; Genetic testing suggests MSI-L or MSS, or tumor biopsy immunohistochemistry reveals pMMR, that is, MSH1, MSH2, MSH6, and PMS2 are all positive.
- Eastern Cooperative Oncology Group (ECOG) score 0-1.
- No previous treatment (including anti-tumor therapy, immunotherapy or pelvic radiation).
- Laboratory tests indicating no contraindications to radiotherapy, chemotherapy and immunotherapy.
- Informed consent form signed.
Who cannot join
- Patients with a previous history of malignant tumors besides rectal cancer.
- Patients with distant metastases before enrollment.
- Patients with positive internal or external iliac lymph nodes are assessed by MRI or CT.
- Patients with obstruction, perforation, or bleeding that require emergency surgery.
- Patients with severe concomitant diseases and estimated survival time ≤ 5 years.
- Allergic to any component of the therapy.
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- Patients who received immunosuppressive or systemic hormone therapy for immunosuppressive purposes within 1 month prior to the initiation of therapy.
- Patients who have received any other experimental drug (including immunotherapy) or participated in another interventional clinical trial within 30 days before screening.
- Factors leading to study termination, such as alcoholism, drug abuse, other serious illnesses (including psychiatric disorders) requiring combination therapy, and patients with severe laboratory abnormalities.
- Patients with congenital or acquired immune deficiency (such as HIV infection).
- Vulnerable groups, including mentally ill, cognitively impaired, critically ill patients, minors, pregnant or lactating women, illiterate, etc.
- Other conditions that investigators consider not suitable for this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Node-sparing Modified Short-Course Radiation Combined With CAPOX and Tislelizumab for MSS Locally Advanced of Middle and Low Rectal Cancer : An Randomized, Prospective, Multicenter, Open-label, Phase III Clinical Trial (mRCAT-III)
This is a randomized, prospective, multicenter, open-label, Phase III clinical trial to evaluate node-sparing modified short-course radiation (Radiation targeting the tumor bed without irradiating surrounding tumor-draining lymph nodes) combined with CAPOX and PD-1 Inhibitor (Tislelizumab) compared with standard short-course radiation combined with CAPOX for patients with MSS middle and low rectal cancer. A total of 170 patients will be enrolled in this trial. The primary endpoint is the rate of pathological complete response (pCR). The EFS rate, ORR, organ preservation rate, long-term prognosis, and adverse effects will also be analyzed.
- Conditions
- Rectal Cancer
- Being tested
- node-sparing modified short-course radiotherapy, PD-1 antibody, Capecitabine, Oxaliplatin, standard short-course radiotherapy
- Keywords
- node-sparing radiation, PD-1, MSS, short-course radioation
- 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
radiation targeting the tumor bed without irradiating surrounding tumor-draining lymph nodes: 25Gy/5Fx
PD-1 antibodyDrug
PD-1 antibody (Tislelizumab): 200mg d1 q3w
CapecitabineDrug
Capecitabine: 1000mg/m2 d1-14 q3w
OxaliplatinDrug
Oxaliplatin: 130mg/m2 d1 q3w
standard short-course radiotherapyRadiation
radiation targeting the tumor bed and surrounding tumor-draining lymph nodes: 25Gy/5Fx
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Participants will receive 5*5Gy node-sparing modified short-course radiation (radiation targeting the tumor bed without irradiating surrounding tumor-draining lymph nodes) concurrently with CAPOX and tislelizumab regimens: Oxaliplatin, 130mg/m2, intravenous infusion,d1 of each cycle; Capecitabine, 1000mg/m2, PO, BID, d1-14 and tislelizumab, 200mg intravenous infusion d1 of each cycle. CAPOX and tislelizumab repeat every 3 weeks for 4 cycles. After treatment, digital rectal examination, pelvic MRI, endoscopy, and biopsy will be performed to evaluate the tumor regression grade. Patients will receive TME surgery after the chemo-immunotherapy, pCR rate and TRG grade will be evaluated. Receives: Radiation: node-sparing modified short-course radiotherapy; Drug: PD-1 antibody; Drug: Capecitabine; Drug: Oxaliplatin |
| Standard Arm | Experimental | Participants will receive 5*5Gy standard short-course radiation (radiation targeting the tumor bed and surrounding tumor-draining lymph nodes) concurrently with CAPOX regimens: Oxaliplatin, 130mg/m2, intravenous infusion,d1 of each cycle; Capecitabine, 1000mg/m2, PO, BID, d1-14. CAPOX repeat every 3 weeks for 4 cycles. After treatment, digital rectal examination, pelvic MRI, endoscopy, and biopsy will be performed to evaluate the tumor regression grade. Patients will receive TME surgery after the chemo-immunotherapy, pCR rate and TRG grade will be evaluated. Receives: Drug: Capecitabine; Drug: Oxaliplatin; Radiation: standard short-course radiotherapy |
| Exploration Arm | Other | Participants will receive 5*5Gy standard short-course radiation (radiation targeting the tumor bed and surrounding tumor-draining lymph nodes) concurrently with CAPOX and tislelizumab regimens: Oxaliplatin, 130mg/m2, intravenous infusion,d1 of each cycle; Capecitabine, 1000mg/m2, PO, BID, d1-14 and tislelizumab, 200mg intravenous infusion d1 of each cycle. CAPOX and tislelizumab repeat every 3 weeks for 4 cycles. After treatment, digital rectal examination, pelvic MRI, endoscopy, and biopsy will be performed to evaluate the tumor regression grade. Patients will receive TME surgery after the chemo-immunotherapy, pCR rate and TRG grade will be evaluated. Receives: Drug: PD-1 antibody; Drug: Capecitabine; Drug: Oxaliplatin; Radiation: standard short-course radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathological complete response (pCR) rate
Pathological complete response (pCR) rate
Measured: within 10 days after completion of surgery
Secondary outcomes (9)
event free survival (EFS)
the time from randomization until relapse or progression
Measured: 3 years after randomization
overall response rate (ORR)
The ORR represents the proportion of patients whose tumor burden decreases by a pre-defined clinically meaningful threshold and is maintained for a minimum required duration, which included complete response (CR) rate and partial response (PR) rate
Measured: within 10 days after completion of chemotherapy
organ preservation rate
patients who are able to retain their rectum/anal sphincter after treatment, without requiring a permanent colostomy.
Measured: within 10 days after completion of chemotherapy
Disease free survival(DFS)
The three-year disease-free survival of patients.
Measured: 3 years after chemotherapy or surgery
Overall survival(OS）
The three-year overall survival of patients.
Measured: 3 years after chemotherapy or surgery
Adverse effects rate
Rate of radiotherapy, chemotherapy and immunotherapy related adverse events
Measured: From date of initiation of treatment until the date of death from any cause, assessed up to 5 years
Rectal specific quality of life assessment via QLQ-CR29 Rectal specific quality of life assessment via QLQ-CR29 Rectal specific quality of life assessment via QLQ-CR29
Rectal specific quality of life according to European Organization for Research and Treatment of Cancer ( EORTC) Quality of life questionnaire QLQ-CR29. scale from 0 to 100, A higher scale represents better function and a higher quality of life.
Measured: Baseline and months 3, 6, 12, 24, 36, 60 after the chemotherapy or surgery
Quality of life assessment via QLQ-C30
Quality of life according to EORTC Quality of life Questionnaire QLQ-C30 version 3.0. Score range from 0 to 100 points. A higher score represents better function and a higher quality of life
Measured: Baseline and months 3, 6, 12, 24, 36, 60 after the chemotherapy or surgery
Validation of the Wexner score
The change of severity of fecal incontinence assessment according to Wexner score. a score from 0-20, where 0 is perfect continence and 20 is complete incontinence.
Measured: Baseline and months 3, 6, 12, 24, 36, 60 after the chemotherapy or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start29 Jul 2024
- Primary completion4 May 2026
- Study completion30 Dec 2028 (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 Sir Run Run Shaw HospitalThe 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
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhangfa Song, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06507371
- Sponsor's protocol ID
- SRRS-mRCAT-III
- Acronym
- mRCAT-III
- Status last verified
- Jun 2026
- First submitted
- 3 Jul 2024
- Last updated
- 30 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Node-sparing Modified Short-Course Radiation Combined With CAPOX and Tislelizumab for MSS Locally Advanced of Middle and Low Rectal Cancer : An Randomized, Prospective, Multicenter, Open-label, Phase III Clinical Trial (mRCAT-III)
- ClinicalTrials.gov ID
- NCT06507371
- Acronym / sponsor ID
- mRCAT-III / SRRS-mRCAT-III
- Conditions
- Rectal Cancer
- Keywords
- node-sparing radiation, PD-1, MSS, short-course radioation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- 29 Jul 2024 (actual)
- Primary completion
- 4 May 2026 (actual)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 18 Jul 2024 (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 is a randomized, prospective, multicenter, open-label, Phase III clinical trial to evaluate node-sparing modified short-course radiation (Radiation targeting the tumor bed without irradiating surrounding tumor-draining lymph nodes) combined with CAPOX and PD-1 Inhibitor (Tislelizumab) compared with standard short-course radiation combined with CAPOX for patients with MSS middle and low rectal cancer. A total of 170 patients will be enrolled in this trial. The primary endpoint is the rate of pathological complete response (pCR). The EFS rate, ORR, organ preservation rate, long-term prognosis, and adverse effects will also be analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Radiation: node-sparing modified short-course radiotherapy, Drug: PD-1 antibody, Drug: Capecitabine, Drug: OxaliplatinParticipants will receive 5*5Gy node-sparing modified short-course radiation (radiation targeting the tumor bed without irradiating surrounding tumor-draining lymph nodes) concurrently with CAPOX and tislelizumab regimens: Oxaliplatin, 130mg/m2, intravenous infusion,d1 of each cycle; Capecitabine, 1000mg/m2, PO, BID, d1-14 and tislelizumab, 200mg intravenous infusion d1 of each cycle. CAPOX and tislelizumab repeat every 3 weeks for 4 cycles. After treatment, digital rectal examination, pelvic MRI, endoscopy, and biopsy will be performed to evaluate the tumor regression grade. Patients will receive TME surgery after the chemo-immunotherapy, pCR rate and TRG grade will be evaluated. |
| Standard Arm | Experimental | Drug: Capecitabine, Drug: Oxaliplatin, Radiation: standard short-course radiotherapyParticipants will receive 5*5Gy standard short-course radiation (radiation targeting the tumor bed and surrounding tumor-draining lymph nodes) concurrently with CAPOX regimens: Oxaliplatin, 130mg/m2, intravenous infusion,d1 of each cycle; Capecitabine, 1000mg/m2, PO, BID, d1-14. CAPOX repeat every 3 weeks for 4 cycles. After treatment, digital rectal examination, pelvic MRI, endoscopy, and biopsy will be performed to evaluate the tumor regression grade. Patients will receive TME surgery after the chemo-immunotherapy, pCR rate and TRG grade will be evaluated. |
| Exploration Arm | Other | Drug: PD-1 antibody, Drug: Capecitabine, Drug: Oxaliplatin, Radiation: standard short-course radiotherapyParticipants will receive 5*5Gy standard short-course radiation (radiation targeting the tumor bed and surrounding tumor-draining lymph nodes) concurrently with CAPOX and tislelizumab regimens: Oxaliplatin, 130mg/m2, intravenous infusion,d1 of each cycle; Capecitabine, 1000mg/m2, PO, BID, d1-14 and tislelizumab, 200mg intravenous infusion d1 of each cycle. CAPOX and tislelizumab repeat every 3 weeks for 4 cycles. After treatment, digital rectal examination, pelvic MRI, endoscopy, and biopsy will be performed to evaluate the tumor regression grade. Patients will receive TME surgery after the chemo-immunotherapy, pCR rate and TRG grade will be evaluated. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients who have a strong willingness to preserve the anus and are willing to receive neoadjuvant therapy.
- Male or Female aged 18-75.
- Patients diagnosed with low rectal cancer within 10 cm from the lower edge of the tumor to the anal verge by pelvic MRI and anorectoscopy, the clinical stage is cT3-4bN0/+M0, and the lymph nodes are limited to the mesorectum.
- Histologically confirmed rectal adenocarcinoma; Genetic testing suggests MSI-L or MSS, or tumor biopsy immunohistochemistry reveals pMMR, that is, MSH1, MSH2, MSH6, and PMS2 are all positive.
- Eastern Cooperative Oncology Group (ECOG) score 0-1.
Key exclusion criteria (12 listed)
- Patients with a previous history of malignant tumors besides rectal cancer.
- Patients with distant metastases before enrollment.
- Patients with positive internal or external iliac lymph nodes are assessed by MRI or CT.
- Patients with obstruction, perforation, or bleeding that require emergency surgery.
- Patients with severe concomitant diseases and estimated survival time ≤ 5 years.
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 |
|---|---|---|
| node-sparing modified short-course radiotherapyradiation targeting the tumor bed without irradiating surrounding tumor-draining lymph nodes: 25Gy/5Fx | Radiation | Treatment Arm |
| PD-1 antibodyPD-1 antibody (Tislelizumab): 200mg d1 q3w | Drug | Exploration Arm, Treatment Arm |
| CapecitabineCapecitabine: 1000mg/m2 d1-14 q3w | Drug | Exploration Arm, Standard Arm, Treatment Arm |
| OxaliplatinOxaliplatin: 130mg/m2 d1 q3w | Drug | Exploration Arm, Standard Arm, Treatment Arm |
| standard short-course radiotherapyradiation targeting the tumor bed and surrounding tumor-draining lymph nodes: 25Gy/5Fx | Radiation | Exploration Arm, Standard Arm |
Primary outcome
pathological complete response (pCR) rate
Time frame: within 10 days after completion of surgery
Pathological complete response (pCR) rate
9 secondary outcomes
event free survival (EFS)
Time frame: 3 years after randomization
overall response rate (ORR)
Time frame: within 10 days after completion of chemotherapy
organ preservation rate
Time frame: within 10 days after completion of chemotherapy
Disease free survival(DFS)
Time frame: 3 years after chemotherapy or surgery
Overall survival(OS）
Time frame: 3 years after chemotherapy or surgery
Adverse effects rate
Time frame: From date of initiation of treatment until the date of death from any cause, assessed up to 5 years
Rectal specific quality of life assessment via QLQ-CR29 Rectal specific quality of life assessment via QLQ-CR29 Rectal specific quality of life assessment via QLQ-CR29
Time frame: Baseline and months 3, 6, 12, 24, 36, 60 after the chemotherapy or surgery
Quality of life assessment via QLQ-C30
Time frame: Baseline and months 3, 6, 12, 24, 36, 60 after the chemotherapy or surgery
Validation of the Wexner score
Time frame: Baseline and months 3, 6, 12, 24, 36, 60 after the chemotherapy or surgery
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 30 Jun 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 node-sparing modified short-course radiotherapy, PD-1 antibody and Capecitabine in people with Rectal Cancer, run by Sir Run Run Shaw Hospital 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 8 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 30 Jun 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathological complete response (pCR) rate (time frame: within 10 days after completion of surgery). 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 30 Jun 2026.