Local Advanced Rectal CancerPhase 3SCRITNCT07686640
Short-Course Radiotherapy Followed by CAPOX With or Without Iparomlimab and Tuvonralimab in pMMR/MSS Locally Advanced Rectal Cancer
A Phase 3 study testing Short-Course Radiotherapy, Consolidation treatment (With ICIs) and Consolidation treatment (Without ICIs) in people with Local Advanced Rectal Cancer and Radiotherapy, run by Shandong Cancer Hospital and Institute at 1 site in China.
Trial summary
This multicenter, randomized, controlled, phase III trial evaluates whether adding iparomlimab and tuvonralimab injection to CAPOX consolidation chemotherapy after short-course radiotherapy improves tumor response in patients with treatment-naive, proficient mismatch repair/microsatellite-stable (pMMR/MSS) locally… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Local Advanced Rectal Cancer, Radiotherapy, Immunotherapy
- What is being tested?
- Short-Course Radiotherapy, Consolidation treatment (With ICIs) and Consolidation treatment (Without ICIs)
- 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
- 180 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2026to 15 Jul 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
- Patients aged 18-75 years with histologically confirmed pMMR/MSS rectal adenocarcinoma are eligible if they have MRI-defined clinical stage II or III disease according to AJCC 8th edition, tumor located within 12 cm from the anal verge, and at least one high-risk feature, including cT4b, cN2, EMVI positivity, MRF positivity, lateral lymph node positivity, tumor deposits, or tumor located ≤5 cm from the anal verge. Patients must have no distant metastasis, ECOG performance status 0-1, life expectancy greater than 6 months, and adequate hematologic, hepatic, and renal function
Who cannot join
- active or prior autoimmune disease requiring systemic treatment, use of immunosuppressive therapy or systemic corticosteroids at immunosuppressive doses, severe hypersensitivity to monoclonal antibodies, uncontrolled cardiac disease, significant coagulopathy or bleeding tendency, active infection, interstitial lung disease or severe pulmonary dysfunction, HIV infection or active hepatitis, prior or concurrent malignancy except specified cured cancers, recent investigational drug use, planned use of other systemic antitumor therapy during the study, pregnancy or breastfeeding, and any other condition judged by the investigator to make participation unsuitable.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shandong Cancer Hospital and Institute
Jinan, Shandong, 0531
Jinbo Yue Doctor, Doctor, 0531-67626442, jbyue@sdfmu.edu.cn
Jinbo Yue Doctor, Doctor, jbyue@sdfmu.edu.cn
About this study
Official title: Short-Course Radiotherapy Followed by CAPOX With or Without Iparomlimab and Tuvonralimab in pMMR/MSS Locally Advanced Rectal Cancer (SCRIT): A Multicenter Phase III Randomized Controlled Trial
This multicenter, randomized, controlled, phase III trial evaluates whether adding iparomlimab and tuvonralimab injection to CAPOX consolidation chemotherapy after short-course radiotherapy improves tumor response in patients with treatment-naive, proficient mismatch repair/microsatellite-stable (pMMR/MSS) locally advanced rectal adenocarcinoma. Eligible patients will be randomly assigned in a 1:1 ratio to receive short-course radiotherapy followed by CAPOX plus iparomlimab and tuvonralimab, or short-course radiotherapy followed by CAPOX alone.
After total neoadjuvant therapy, patients with a clinical complete response may undergo a Watch-and-Wait strategy, whereas other patients will undergo total mesorectal excision according to standard clinical practice. The primary endpoint is complete response rate, defined as pathologic complete response after surgery or clinical complete response sustained for more than 1 year. Secondary endpoints include 3-year relapse-free survival, 3-year overall survival, sphincter preservation rate, and grade 3-4 acute adverse events. Exploratory analyses will assess tissue and blood biomarkers associated with treatment response.
- Conditions
- Local Advanced Rectal Cancer, Radiotherapy, Immunotherapy
- Being tested
- Short-Course Radiotherapy, Consolidation treatment (With ICIs), Consolidation treatment (Without ICIs)
- Keywords
- local advanced rectal cancer, radiotherapy, immunotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short-Course RadiotherapyRadiation
Short-course external-beam radiotherapy will be delivered to the rectal primary tumor and corresponding lymphatic drainage regions using IMRT or VMAT. The prescribed dose is 25 Gy in 5 fractions over 1 week. No concurrent chemotherapy will be administered during short-course radiotherapy.
Consolidation treatment (With ICIs)Drug
Iparomlimab and tuvonralimab injection will be administered at 5 mg/kg by intravenous infusion every 21 days for 6 cycles. CAPOX chemotherapy will consist of oxaliplatin 130 mg/m² intravenously on day 1 plus capecitabine 1000 mg/m² orally twice daily on days 1-14 of each 21-day cycle, for 6 cycles.
Consolidation treatment (Without ICIs)Drug
CAPOX chemotherapy will consist of oxaliplatin 130 mg/m² intravenously on day 1 plus capecitabine 1000 mg/m² orally twice daily on days 1-14 of each 21-day cycle, for 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Short-Course Radiotherapy + CAPOX + Iparomlimab and Tuvonralimab Radiotherapy: Short-course external-beam radiotherapy will be delivered to the rectal primary tumor and corresponding lymphatic drainage regions using IMRT or VMAT. The prescribed dose is 25 Gy in 5 fractions over 1 week. No concurrent chemotherapy will be administered during short-course radiotherapy.
Consolidation treatment: Iparomlimab and tuvonralimab injection will be administered at 5 mg/kg by intravenous infusion every 21 days for 6 cycles. CAPOX chemotherapy will consist of oxaliplatin 130 mg/m² intravenously on day 1 plus capecitabine 1000 mg/m² orally twice daily on days 1-14 of each 21-day cycle, for 6 cycles. Receives: Radiation: Short-Course Radiotherapy; Drug: Consolidation treatment (With ICIs) |
| Control | Active comparator | Short-Course Radiotherapy + CAPOX Radiotherapy: Short-course external-beam radiotherapy will be delivered to the rectal primary tumor and corresponding lymphatic drainage regions using IMRT or VMAT. The prescribed dose is 25 Gy in 5 fractions over 1 week. No concurrent chemotherapy will be administered during short-course radiotherapy.
Consolidation treatment: CAPOX chemotherapy will consist of oxaliplatin 130 mg/m² intravenously on day 1 plus capecitabine 1000 mg/m² orally twice daily on days 1-14 of each 21-day cycle, for 6 cycles. Receives: Radiation: Short-Course Radiotherapy; Drug: Consolidation treatment (Without ICIs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response (CR) Rate
Complete response rate is defined as the proportion of patients who achieve either pathologic complete response (pCR) after surgery or sustained clinical complete response (cCR) for more than 1 year during Watch-and-Wait follow-up.
Measured: From randomization to completion of definitive response assessment, including surgical pathological assessment after total neoadjuvant therapy or confirmation of sustained clinical complete response after at least 12 months of Watch-and-Wait follow-up
Secondary outcomes (4)
3-Year Relapse-Free Survival (RFS)
Relapse-free survival is defined as the time from randomization to the first evidence of disease relapse or recurrence. Patients without relapse/recurrence or death will be censored at the date of last disease assessment.
Measured: From randomization to the first documented disease relapse/recurrence, death from any cause, or 3 years after randomization, whichever occurs first.
3-Year Overall Survival (OS)
Overall survival is defined as the time from randomization to death from any cause. Patients who are alive at the time of analysis will be censored at the date of last known survival follow-up.
Measured: From randomization to death from any cause or 3 years after randomization, whichever occurs first.
Sphincter Preservation Rate
Sphincter preservation rate is defined as the proportion of patients who successfully preserve anal sphincter structure and function and avoid permanent colostomy.
Measured: From randomization to completion of definitive surgery, or to at least 12 months after initiation of Watch-and-Wait follow-up for patients who do not undergo surgery; approximately up to 18-24 months after randomization.
Incidence of Grade 3-4 Acute Adverse Events
Acute adverse events will be graded and recorded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0. The incidence of grade 3-4 acute adverse events will be summarized by treatment arm.
Measured: From the start of study treatment to 30 days after completion of neoadjuvant treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start15 Aug 2026
- Primary completion15 Jul 2029 (estimated)
- Study completion15 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Local Advanced Rectal CancerStudies of the same condition, open and under way.
- 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
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Cancer Hospital and Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinbo Yue, Shandong Cancer Hospital and Institute
- Investigators
- Jinbo Yue, Doctor, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07686640
- Sponsor's protocol ID
- SDZLEC2026-051-002
- Acronym
- SCRIT
- Status last verified
- Aug 2026
- First submitted
- 30 Jun 2026
- Last updated
- 18 Aug 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 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Course Radiotherapy Followed by CAPOX With or Without Iparomlimab and Tuvonralimab in pMMR/MSS Locally Advanced Rectal Cancer (SCRIT): A Multicenter Phase III Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07686640
- Acronym / sponsor ID
- SCRIT / SDZLEC2026-051-002
- Conditions
- Local Advanced Rectal Cancer, Radiotherapy, Immunotherapy
- Keywords
- local advanced rectal cancer, radiotherapy, immunotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Shandong Cancer Hospital and InstituteUniversity, hospital or other
- Study start
- 15 Aug 2026 (actual)
- Primary completion
- 15 Jul 2029 (estimated)
- Study completion
- 15 Jul 2030 (estimated)
- First posted
- 7 Jul 2026 (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 multicenter, randomized, controlled, phase III trial evaluates whether adding iparomlimab and tuvonralimab injection to CAPOX consolidation chemotherapy after short-course radiotherapy improves tumor response in patients with treatment-naive, proficient mismatch repair/microsatellite-stable (pMMR/MSS) locally advanced rectal adenocarcinoma. Eligible patients will be randomly assigned in a 1:1 ratio to receive short-course radiotherapy followed by CAPOX plus iparomlimab and tuvonralimab, or short-course radiotherapy followed by CAPOX alone.
After total neoadjuvant therapy, patients with a clinical complete response may undergo a Watch-and-Wait strategy, whereas other patients will undergo total mesorectal excision according to standard clinical practice. The primary endpoint is complete response rate, defined as pathologic complete response after surgery or clinical complete response sustained for more than 1 year. Secondary endpoints include 3-year relapse-free survival, 3-year overall survival, sphincter preservation rate, and grade 3-4 acute adverse events. Exploratory analyses will assess tissue and blood biomarkers associated with treatment response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Radiation: Short-Course Radiotherapy, Drug: Consolidation treatment (With ICIs)Short-Course Radiotherapy + CAPOX + Iparomlimab and Tuvonralimab Radiotherapy: Short-course external-beam radiotherapy will be delivered to the rectal primary tumor and corresponding lymphatic drainage regions using IMRT or VMAT. The prescribed dose is 25 Gy in 5 fractions over 1 week. No concurrent chemotherapy will be administered during short-course radiotherapy. Consolidation treatment: Iparomlimab and tuvonralimab injection will be administered at 5 mg/kg by intravenous infusion every 21 days for 6 cycles. CAPOX chemotherapy will consist of oxaliplatin 130 mg/m² intravenously on day 1 plus capecitabine 1000 mg/m² orally twice daily on days 1-14 of each 21-day cycle, for 6 cycles. |
| Control | Active comparator | Radiation: Short-Course Radiotherapy, Drug: Consolidation treatment (Without ICIs)Short-Course Radiotherapy + CAPOX Radiotherapy: Short-course external-beam radiotherapy will be delivered to the rectal primary tumor and corresponding lymphatic drainage regions using IMRT or VMAT. The prescribed dose is 25 Gy in 5 fractions over 1 week. No concurrent chemotherapy will be administered during short-course radiotherapy. Consolidation treatment: CAPOX chemotherapy will consist of oxaliplatin 130 mg/m² intravenously on day 1 plus capecitabine 1000 mg/m² orally twice daily on days 1-14 of each 21-day cycle, for 6 cycles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 18-75 years with histologically confirmed pMMR/MSS rectal adenocarcinoma are eligible if they have MRI-defined clinical stage II or III disease according to AJCC 8th edition, tumor located within 12 cm from the anal verge, and at least one high-risk feature, including cT4b, cN2, EMVI positivity, MRF positivity, lateral lymph node positivity, tumor deposits, or tumor located ≤5 cm from the anal verge. Patients must have no distant metastasis, ECOG performance status 0-1, life expectancy greater than 6 months, and adequate hematologic, hepatic, and renal function
Key exclusion criteria (1 listed)
- active or prior autoimmune disease requiring systemic treatment, use of immunosuppressive therapy or systemic corticosteroids at immunosuppressive doses, severe hypersensitivity to monoclonal antibodies, uncontrolled cardiac disease, significant coagulopathy or bleeding tendency, active infection, interstitial lung disease or severe pulmonary dysfunction, HIV infection or active hepatitis, prior or concurrent malignancy except specified cured cancers, recent investigational drug use, planned use of other systemic antitumor therapy during the study, pregnancy or breastfeeding, and any other condition judged by the investigator to make participation unsuitable.
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 |
|---|---|---|
| Short-Course RadiotherapyShort-course external-beam radiotherapy will be delivered to the rectal primary tumor and corresponding lymphatic drainage regions using IMRT or VMAT. The prescribed dose is 25 Gy in 5 fractions over 1 week. No concurrent chemotherapy will be administered during short-course radiotherapy. | Radiation | Control, Treatment |
| Consolidation treatment (With ICIs)Iparomlimab and tuvonralimab injection will be administered at 5 mg/kg by intravenous infusion every 21 days for 6 cycles. CAPOX chemotherapy will consist of oxaliplatin 130 mg/m² intravenously on day 1 plus capecitabine 1000 mg/m² orally twice daily on days 1-14 of each 21-day cycle, for 6 cycles. | Drug | Treatment |
| Consolidation treatment (Without ICIs)CAPOX chemotherapy will consist of oxaliplatin 130 mg/m² intravenously on day 1 plus capecitabine 1000 mg/m² orally twice daily on days 1-14 of each 21-day cycle, for 6 cycles. | Drug | Control |
Primary outcome
Complete Response (CR) Rate
Time frame: From randomization to completion of definitive response assessment, including surgical pathological assessment after total neoadjuvant therapy or confirmation of sustained clinical complete response after at least 12 months of Watch-and-Wait follow-up
Complete response rate is defined as the proportion of patients who achieve either pathologic complete response (pCR) after surgery or sustained clinical complete response (cCR) for more than 1 year during Watch-and-Wait follow-up.
4 secondary outcomes
3-Year Relapse-Free Survival (RFS)
Time frame: From randomization to the first documented disease relapse/recurrence, death from any cause, or 3 years after randomization, whichever occurs first.
3-Year Overall Survival (OS)
Time frame: From randomization to death from any cause or 3 years after randomization, whichever occurs first.
Sphincter Preservation Rate
Time frame: From randomization to completion of definitive surgery, or to at least 12 months after initiation of Watch-and-Wait follow-up for patients who do not undergo surgery; approximately up to 18-24 months after randomization.
Incidence of Grade 3-4 Acute Adverse Events
Time frame: From the start of study treatment to 30 days after completion of neoadjuvant treatment.
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 18 Aug 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.
Jinbo Yue, Doctor principal investigator
Study Principal Investigator
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 Short-Course Radiotherapy, Consolidation treatment (With ICIs) and Consolidation treatment (Without ICIs) in people with Local Advanced Rectal Cancer and Radiotherapy, run by Shandong Cancer Hospital and Institute 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 1 inclusion and 1 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 18 Aug 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 Jinbo Yue Doctor (0531-67626442, jbyue@sdfmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response (CR) Rate (time frame: From randomization to completion of definitive response assessment, including surgical pathological assessment after total neoadjuvant therapy or confirmation of sustained clinical complete response after at least 12 months of Watch-and-Wait follow-up). 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 18 Aug 2026.