Locally Advanced Rectal Cancer (LARC)Phase 2/3NCT07879586
Neoadjuvant Chemoradiotherapy Plus PD-1 Blockade ± CTLA-4 Blockade for High-Risk Locally Advanced Rectal Cancer (pMMR/MSS): A National Multicenter, Prospective, Randomized Controlled Trial
A Phase 2/3 study testing Ipilimumab & Sintilimab and Sintilimab in people with Locally Advanced Rectal Cancer (LARC), run by Yao Hongwei.
Trial summary
The goal of this clinical trial is to learn whether adding ipilimumab N01 to standard pre-surgery treatment with radiation, chemotherapy, and sintilimab can improve outcomes for people with high-risk, locally advanced rectal cancer whose tumors are mismatch repair-proficient and microsatellite stable (pMMR/MSS). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Rectal Cancer (LARC)
- What is being tested?
- Ipilimumab & Sintilimab and Sintilimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Oct 2032
- Phase
- Phase 2/3
- 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
- 1: Signed written informed consent and voluntary participation in this study
- 2: Aged 18-75 years, male or female
- 3: Rectal adenocarcinoma confirmed by histopathology, with immunohistochemistry results indicating pMMR or genetic testing results indicating MSS
- 4: High-risk locally advanced rectal cancer assessed by MRI, without distant metastasis, and meeting at least one of the following: T4Nany, TanyN2, MRF+, lateral lymph node+, EMVI+; no tumor deposits, or no high-risk factors for local recurrence as judged by the investigator
- 5: The lower edge of the tumor is ≤10 cm from the anal verge
- 6: Surgically resectable
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- 7: Able to swallow tablets normally
- 8: ECOG PS 0-1
- 9: No prior antitumor treatment for rectal cancer, including radiotherapy, chemotherapy, surgery, etc.
- 10: Planned to undergo surgery after completion of neoadjuvant therapy
- 11: No contraindications to surgery
- 12: Normal function of major organs
Who cannot join
- 1: History of allergy to monoclonal antibodies, sintilimab, ipilimumab N01, oxaliplatin, capecitabine, or any other excipients
- 2: Previously received or currently receiving any of the following treatments: a) Any surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc. for the tumor; b) Within 2 weeks before the first use of the study drug, currently using immunosuppressive drugs or systemic hormone therapy for the purpose of immunosuppression (dose > 10 mg/day prednisone or equivalent); in the absence of active autoimmune disease, inhaled or topical steroids and adrenal corticosteroid replacement at a dose > 10 mg/day prednisone or equivalent are permitted; c) Received a live attenuated vaccine within 4 weeks before the first use of the study drug; d) Underwent major surgery or had severe trauma within 4 weeks before the first use of the study drug
- 3: Has any active autoimmune disease or a history of autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (may be considered for enrollment after hormone replacement therapy); patients with psoriasis or childhood asthma/allergy that has completely resolved and requires no intervention in adulthood may be considered for enrollment, but patients who require medical intervention with bronchodilators must not be enrolled
- 4: History of immunodeficiency, including positive HIV test, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation or allogeneic bone marrow transplantation
- 5: Presence of poorly controlled cardiac clinical symptoms or diseases, including but not limited to: (1) heart failure of NYHA class II or above, (2) unstable angina, (3) myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmias without clinical intervention or still poorly controlled after clinical intervention
- 6: Severe infection (CTCAE > grade 2) within 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia, infectious complications, etc. requiring hospitalization; baseline chest imaging suggesting active pulmonary inflammation, presence of symptoms and signs of infection within 14 days before the first use of the study drug, or need for oral or intravenous antibiotic treatment, except for prophylactic antibiotic use; active pulmonary tuberculosis infection found by medical history or CT examination, or history of active pulmonary tuberculosis infection within 1 year before enrollment, or history of active pulmonary tuberculosis infection more than 1 year ago but without regular treatment
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- 7: Presence of active hepatitis B (HBV DNA ≥ 2000 IU/mL or 10^4 copies/mL), hepatitis C (positive hepatitis C antibody and HCV RNA above the lower limit of detection of the assay method)
- 8: Diagnosed with other malignant tumors within 5 years before the first use of the study drug, unless the malignant tumor has a low risk of metastasis or death (5-year survival rate > 90%), such as adequately treated basal cell carcinoma or squamous cell skin cancer or carcinoma in situ of the cervix, etc., may be considered for enrollment
- 9: Pregnant or breastfeeding women
- 10: As judged by the investigator, presence of other factors that may lead to forced early termination of the study, such as other serious diseases (including mental illness) requiring concomitant treatment, alcoholism, drug abuse, family or social factors, or factors that may affect subject safety or compliance
About this study
Official title: Neoadjuvant Therapy Combined With Dual Immunotherapy for Rectal Cancer: A Clinical Study
The goal of this clinical trial is to learn whether adding ipilimumab N01 to standard pre-surgery treatment with radiation, chemotherapy, and sintilimab can improve outcomes for people with high-risk, locally advanced rectal cancer whose tumors are mismatch repair-proficient and microsatellite stable (pMMR/MSS). The study will also evaluate the safety of these treatments and whether some participants may be able to avoid major rectal surgery after a strong response.
- Conditions
- Locally Advanced Rectal Cancer (LARC)
- Being tested
- Ipilimumab & Sintilimab, Sintilimab
- Keywords
- Immunotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ipilimumab & SintilimabDrug
In Experimental group，subjects will receive long-course neoadjuvant radiotherapy, followed by chemotherapy combined with immunotherapy: Ipilimumab \& Sintilimab.
SintilimabDrug
In Control group，subjects will receive long-course neoadjuvant radiotherapy, followed by chemotherapy combined with immunotherapy: Sintilimab.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | In control group，subjects will receive long-course neoadjuvant radiotherapy, followed by chemotherapy combined with immunotherapy: Sintilimab. The surgical approach and the use of adjuvant chemotherapy will be determined based on the tumor's response to neoadjuvant treatment. Receives: Drug: Sintilimab |
| Experimental group | Experimental | In experimental group，subjects will receive long-course neoadjuvant radiotherapy, followed by chemotherapy combined with immunotherapy: Ipilimumab \& Sintilimab. The surgical approach and the use of adjuvant chemotherapy will be determined based on the tumor's response to neoadjuvant treatment. Receives: Drug: Ipilimumab & Sintilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete remission rate
The complete response rate (CR) is defined as follows: Participants who undergo total mesorectal excision (TME) or local excision must achieve a pathological complete response (pCR; ypT0N0). Participants who do not undergo surgery and enter a watch-and-wait (W\&W) program must achieve a clinical complete response (cCR), as determined by a comprehensive assessment including digital rectal examination (DRE), endoscopy, pelvic magnetic resonance imaging (MRI), and tumor markers. The cCR must be confirmed by at least one repeat assessment performed 6-8 weeks later. If a participant is initially assessed as having a cCR but subsequently undergoes surgery, the final pathological findings will determine the response status. The same CR criteria will be applied to both study groups.
Measured: From enrollment to the end of treatment at 19 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2029 (estimated)
- Study completion1 Oct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Rectal Cancer (LARC)Studies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yao Hongwei
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yao Hongwei, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07879586
- Sponsor's protocol ID
- 2026-P2-584-01
- Status last verified
- Oct 2026
- First submitted
- 11 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Therapy Combined With Dual Immunotherapy for Rectal Cancer: A Clinical Study
- ClinicalTrials.gov ID
- NCT07879586
- Acronym / sponsor ID
- 2026-P2-584-01
- Conditions
- Locally Advanced Rectal Cancer (LARC)
- Keywords
- Immunotherapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Yao HongweiUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2029 (estimated)
- Study completion
- 1 Oct 2032 (estimated)
- First posted
- 19 Oct 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.
The goal of this clinical trial is to learn whether adding ipilimumab N01 to standard pre-surgery treatment with radiation, chemotherapy, and sintilimab can improve outcomes for people with high-risk, locally advanced rectal cancer whose tumors are mismatch repair-proficient and microsatellite stable (pMMR/MSS). The study will also evaluate the safety of these treatments and whether some participants may be able to avoid major rectal surgery after a strong response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: SintilimabIn control group，subjects will receive long-course neoadjuvant radiotherapy, followed by chemotherapy combined with immunotherapy: Sintilimab. The surgical approach and the use of adjuvant chemotherapy will be determined based on the tumor's response to neoadjuvant treatment. |
| Experimental group | Experimental | Drug: Ipilimumab & SintilimabIn experimental group，subjects will receive long-course neoadjuvant radiotherapy, followed by chemotherapy combined with immunotherapy: Ipilimumab \& Sintilimab. The surgical approach and the use of adjuvant chemotherapy will be determined based on the tumor's response to neoadjuvant treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 1: Signed written informed consent and voluntary participation in this study
- 2: Aged 18-75 years, male or female
- 3: Rectal adenocarcinoma confirmed by histopathology, with immunohistochemistry results indicating pMMR or genetic testing results indicating MSS
- 4: High-risk locally advanced rectal cancer assessed by MRI, without distant metastasis, and meeting at least one of the following: T4Nany, TanyN2, MRF+, lateral lymph node+, EMVI+; no tumor deposits, or no high-risk factors for local recurrence as judged by the investigator
- 5: The lower edge of the tumor is ≤10 cm from the anal verge
Key exclusion criteria (10 listed)
- 1: History of allergy to monoclonal antibodies, sintilimab, ipilimumab N01, oxaliplatin, capecitabine, or any other excipients
- 2: Previously received or currently receiving any of the following treatments: a) Any surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc. for the tumor; b) Within 2 weeks before the first use of the study drug, currently using immunosuppressive drugs or systemic hormone therapy for the purpose of immunosuppression (dose > 10 mg/day prednisone or equivalent); in the absence of active autoimmune disease, inhaled or topical steroids and adrenal corticosteroid replacement at a dose > 10 mg/day prednisone or equivalent are permitted; c) Received a live attenuated vaccine within 4 weeks before the first use of the study drug; d) Underwent major surgery or had severe trauma within 4 weeks before the first use of the study drug
- 3: Has any active autoimmune disease or a history of autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (may be considered for enrollment after hormone replacement therapy); patients with psoriasis or childhood asthma/allergy that has completely resolved and requires no intervention in adulthood may be considered for enrollment, but patients who require medical intervention with bronchodilators must not be enrolled
- 4: History of immunodeficiency, including positive HIV test, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation or allogeneic bone marrow transplantation
- 5: Presence of poorly controlled cardiac clinical symptoms or diseases, including but not limited to: (1) heart failure of NYHA class II or above, (2) unstable angina, (3) myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmias without clinical intervention or still poorly controlled after clinical intervention
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 |
|---|---|---|
| Ipilimumab & SintilimabIn Experimental group，subjects will receive long-course neoadjuvant radiotherapy, followed by chemotherapy combined with immunotherapy: Ipilimumab \& Sintilimab. | Drug | Experimental group |
| SintilimabIn Control group，subjects will receive long-course neoadjuvant radiotherapy, followed by chemotherapy combined with immunotherapy: Sintilimab. | Drug | Control group |
Primary outcome
Complete remission rate
Time frame: From enrollment to the end of treatment at 19 weeks
The complete response rate (CR) is defined as follows: Participants who undergo total mesorectal excision (TME) or local excision must achieve a pathological complete response (pCR; ypT0N0). Participants who do not undergo surgery and enter a watch-and-wait (W\&W) program must achieve a clinical complete response (cCR), as determined by a comprehensive assessment including digital rectal examination (DRE), endoscopy, pelvic magnetic resonance imaging (MRI), and tumor markers. The cCR must be confirmed by at least one repeat assessment performed 6-8 weeks later. If a participant is initially assessed as having a cCR but subsequently undergoes surgery, the final pathological findings will determine the response status. The same CR criteria will be applied to both study groups.
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 19 Oct 2026.
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Active, not recruitingObservational study
Radiological Markers in Locally Advanced Rectal Cancer
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ipilimumab & Sintilimab and Sintilimab in people with Locally Advanced Rectal Cancer (LARC), run by Yao Hongwei.
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 12 inclusion and 10 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 19 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Complete remission rate (time frame: From enrollment to the end of treatment at 19 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 19 Oct 2026.