MSI-H/dMMR Locally Advanced Rectal AdenocarcinomaPhase 2sintilimabNCT07750951
Single-arm, Phase II Clinical Study Evaluating the Safety and Efficacy of Sintilimab Combined With IBI-310 and Chemotherapy as Neoadjuvant Therapy for Locally Advanced Rectal Cancer
A Phase 2 study testing Cindilimab、IBI310、Capecitabine、Oxaliplatin in people with MSI-H/dMMR Locally Advanced Rectal Adenocarcinoma, run by Xijing Hospital at 1 site in China.
Trial summary
Observation and evaluation of the safety and efficacy of PD-1 antibody combined with IBI310 and neoadjuvant chemotherapy in the treatment of locally advanced rectal cancer Primary objectives: Pathological complete response (pCR) rate; Secondary objectives: Treatment-related adverse events (CTCAE 5.0), clinical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MSI-H/dMMR Locally Advanced Rectal Adenocarcinoma
- What is being tested?
- Cindilimab、IBI310、Capecitabine、Oxaliplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 29 May 2026to Apr 2027
- Phase
- Phase 2
- 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) Sign written informed consent before implementing any trial related processes;
- 2) Male or female, age ≥ 18 years;
- 3) ECOG score 0-1;
- 4) The primary lesion is a locally advanced rectal adenocarcinoma with histopathologically confirmed MSI-H/dMMR characteristics.;
- 5) Combined with endoscopic ultrasonography / rectal MR scan diagnosis, patients with clinical stage t2-4a or n+m0 were evaluated for lesion resectability;
- 6) According to the response evaluation criteria for solid tumors (RECIST version 1.1), there was at least one measurable lesion on imaging;
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- 7) The patient has not received any anti-tumor treatment in the past, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy Therapeutics et al;
- 8) Sufficient organ function, subjects need to meet the following laboratory indicators:
- The absolute neutrophil count (ANC)≥1.5x109/L without granulocyte colony stimulating factor in the past 14 days;
- Platelets≥100×109/L without blood transfusion in recent 14 days;
- Hemoglobin >9g/dl without blood transfusion or use of erythropoietin in recent 14 days;
- Total bilirubin ≤ 1.5×upper limit of normal (ULN);
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤2.5×ULN;
- Serum creatinine≤1.5×ULN and creatinine clearance (calculated by Cockcroft Gault formula)≥60ml/min;
- Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT)≤1.5times ULN;
- Thyroid function was normal, defined as thyroid stimulating hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled;
- The myocardial enzyme spectrum is within the normal range (for example, simple laboratory abnormalities that are not clinically significant according to the comprehensive judgment of the investigator are also allowed to be enrolled).
- 9) Female subjects of childbearing age should receive a urine or serum pregnancy test with negative results within 3 days before receiving the first study drug administration (day 1 of cycle 1). If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Women of non reproductive age were defined as having been postmenopausal for at least 1 year, or having undergone surgical sterilization or hysterectomy;
- 10) If there is a risk of conception, all subjects (whether male or female) need to use contraceptive measures with an annual failure rate of less than 1% during the whole treatment period until 120 days after the last dose of study drug (or 180 days after the last dose of chemotherapy drug).
Who cannot join
- 1) Diagnose distant metastasis through CT/MR/EUS;
- 2) Other malignant tumors (excluding basal cell or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ or breast cancer) in the past 5 years;
- 3) Severe intestinal obstruction;
- 4) Currently participating in interventional clinical research treatment, or having received other investigational drugs or used investigational devices within 4 weeks prior to the first administration;
- 5) Previously received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or drugs that stimulate or synergistically inhibit T cell receptors (such as CTLA-4, OX-40, CD137);
- 6) Within 2 weeks before the first administration, he has received systematic systemic treatment with traditional Chinese patent medicines and simple preparations with anti-tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin, except for local use to control pleural effusion);
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- 7) An active autoimmune disease requiring systemic treatment (such as the use of disease relieving drugs, corticosteroids, or immunosuppressants) has occurred within 2 years prior to the first administration. Alternative therapies (such as thyroid hormone, insulin, or physiological glucocorticoids used for adrenal or pituitary insufficiency) are not considered systemic treatments;
- 8) Within 7 days prior to the first administration of the study, the individual was receiving systemic corticosteroid therapy (excluding topical corticosteroids via nasal spray, inhalation, or other routes) or any other form of immunosuppressive therapy; Note: Physiological doses of glucocorticoids (≤ 10 mg/day of prednisone or equivalent) are allowed to be used;
- 9) Known allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
- 10) Individuals who are known to be allergic to the active ingredients or excipients of the investigational drug Xindilimumab, IBI310;
- 11) Individuals with multiple factors that affect oral medication, such as inability to swallow, post gastrointestinal resection, chronic diarrhea, and intestinal obstruction;
- 12) Not fully recovered from toxicity and/or complications caused by any intervention measures before starting treatment (i.e. ≤ grade 1 or baseline, excluding fatigue or hair loss);
- 13) Known history of human immunodeficiency virus (HIV) infection (i.e. HIV1/2 antibody positive);
- 14) Active hepatitis B without treatment (defined as HBsAg positive and HBV-DNA copy number detected is greater than the upper limit of normal value in the laboratory of the research center);
- Note: hepatitis B patients who meet the following criteria can also be included in the group:
- Prior to the first administration, if the HBV viral load is less than 1000 copies/ml (200 IU/ml), subjects should receive anti HBV treatment throughout the entire study chemotherapy period to avoid viral reactivation;
- For subjects with anti HBc (+), HBsAg (-), anti HBs (-), and HBV viral load (-), prophylactic anti HBV treatment is not necessary, but close monitoring of viral reactivation is required;
- Active HCV infected subjects (HCV antibody positive and HCV-RNA level above the detection limit);
- 15) Vaccination with live vaccine within 30 days prior to the first administration (Day 1 of the first cycle); Note: It is allowed to receive inactivated vaccine for seasonal influenza within 30 days before the first administration; However, intranasal administration of attenuated live influenza vaccine is not allowed.
- 16) Pregnant or lactating women;
- 17) There are any serious or uncontrollable systemic diseases, such as:
- Resting electrocardiogram shows significant and difficult to control abnormalities in rhythm, conduction, or morphology, such as complete left bundle branch block, grade II or higher heart block, ventricular arrhythmia, or atrial fibrillation; b) Unstable angina pectoris, congestive heart failure, chronic heart failure classified as NYHA ≥ 2; c) Myocardial infarction occurred within 6 months prior to randomization; d) Poor blood pressure control (systolic blood pressure>140 mmHg, diastolic blood pressure>90 mmHg); e) A history of non infectious pneumonia requiring corticosteroid treatment within the year prior to the first administration, or current clinical active interstitial lung disease; f) Active pulmonary tuberculosis; g) There are active or uncontrolled infections that require systemic treatment; h) There is clinical active diverticulitis, abdominal abscess, and gastrointestinal obstruction; i) Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis; j) Poor control of diabetes (FBG>10mmol/L); k) Urine routine shows urinary protein ≥++and confirms 24-hour urinary protein quantification>1.0 g; l) Patients with mental disorders who are unable to cooperate with treatment;
- 18) Medical history or disease evidence, abnormal treatment or laboratory test values that may interfere with the trial results, hinder the full participation of the subjects in the study, or other situations that the researchers believe are not suitable for inclusion. The researchers believe that there are other potential risks and they are not suitable to participate in this study.
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
The First Affiliated Hospital,the Air Force Medical University
Xi'an, Shaanxi, 710032
liushushang, +86 15721985836, liushushang8@126.com
About this study
Observation and evaluation of the safety and efficacy of PD-1 antibody combined with IBI310 and neoadjuvant chemotherapy in the treatment of locally advanced rectal cancer
Primary objectives:
Pathological complete response (pCR) rate;
Secondary objectives:
Treatment-related adverse events (CTCAE 5.0), clinical complete response (cCR) rate, major pathological response (MPR) rate, R0 resection rate, sphincter preservation rate, surgical complications, 3-year disease-free survival (DFS), and overall survival (OS);
- Being tested
- Cindilimab、IBI310、Capecitabine、Oxaliplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cindilimab、IBI310、Capecitabine、OxaliplatinDrug
- Neoadjuvant treatment phase The total treatment duration was 6 weeks PD-1：200mg IV, D1, Q3W IBI310：1.0mg/kg IV, D1,Q3W Capecitabine: 1000 mg/m2, Po, bid, d1-d14, q3w Oxaliplatin: 130 mg/m2, IV, D1, q3w B. Surgical treatment stage All patients underwent preoperative evaluation within 4-6 weeks after the end of neoadjuvant therapy,
- CCR: waiting for observation follow-up;
- yct0-2n0m0: local resection follow-up;
- yct3-4a or n+:tme- follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | PD-1：200mg IV, D1, Q3W IBI310：1.0mg/kg IV, D1,Q3W Capecitabine: 1000 mg/m2, Po, bid, d1-d14, q3w Oxaliplatin: 130 mg/m2, IV, D1, q3w Receives: Drug: Cindilimab、IBI310、Capecitabine、Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response (PCR) rate
The proportion of subjects with no residual viable tumor cells and negative lymph nodes in the total subjects
Measured: Surgery (within 4-6 weeks of the last administration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start29 May 2026
- Primary completionNov 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MSI-H/dMMR Locally Advanced Rectal AdenocarcinomaStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07750951
- Sponsor's protocol ID
- KY20262117-F-1
- Acronym
- sintilimab
- Status last verified
- Apr 2026
- First submitted
- 23 Jul 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- 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 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-arm, Phase II Clinical Study Evaluating the Safety and Efficacy of Sintilimab Combined With IBI-310 and Chemotherapy as Neoadjuvant Therapy for Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT07750951
- Acronym / sponsor ID
- sintilimab / KY20262117-F-1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 29 May 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 6 Aug 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.
Observation and evaluation of the safety and efficacy of PD-1 antibody combined with IBI310 and neoadjuvant chemotherapy in the treatment of locally advanced rectal cancer
Primary objectives:
Pathological complete response (pCR) rate;
Secondary objectives:
Treatment-related adverse events (CTCAE 5.0), clinical complete response (cCR) rate, major pathological response (MPR) rate, R0 resection rate, sphincter preservation rate, surgical complications, 3-year disease-free survival (DFS), and overall survival (OS);
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Cindilimab、IBI310、Capecitabine、OxaliplatinPD-1：200mg IV, D1, Q3W IBI310：1.0mg/kg IV, D1,Q3W Capecitabine: 1000 mg/m2, Po, bid, d1-d14, q3w Oxaliplatin: 130 mg/m2, IV, D1, q3w |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 1) Sign written informed consent before implementing any trial related processes;
- 2) Male or female, age ≥ 18 years;
- 3) ECOG score 0-1;
- 4) The primary lesion is a locally advanced rectal adenocarcinoma with histopathologically confirmed MSI-H/dMMR characteristics.;
- 5) Combined with endoscopic ultrasonography / rectal MR scan diagnosis, patients with clinical stage t2-4a or n+m0 were evaluated for lesion resectability;
Key exclusion criteria (23 listed)
- 1) Diagnose distant metastasis through CT/MR/EUS;
- 2) Other malignant tumors (excluding basal cell or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ or breast cancer) in the past 5 years;
- 3) Severe intestinal obstruction;
- 4) Currently participating in interventional clinical research treatment, or having received other investigational drugs or used investigational devices within 4 weeks prior to the first administration;
- 5) Previously received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or drugs that stimulate or synergistically inhibit T cell receptors (such as CTLA-4, OX-40, CD137);
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 |
|---|---|---|
| Cindilimab、IBI310、Capecitabine、OxaliplatinA. Neoadjuvant treatment phase The total treatment duration was 6 weeks PD-1：200mg IV, D1, Q3W IBI310：1.0mg/kg IV, D1,Q3W Capecitabine: 1000 mg/m2, Po, bid, d1-d14, q3w Oxaliplatin: 130 mg/m2, IV, D1, q3w B. Surgical treatment stage All patients underwent preoperative evaluation within 4-6 weeks after the end of neoadjuvant therapy, * CCR: waiting for observation follow-up; * yct0-2n0m0: local resection follow-up; * yct3-4a or n+:tme- follow-up. | Drug | Treatment group |
Primary outcome
Pathological complete response (PCR) rate
Time frame: Surgery (within 4-6 weeks of the last administration)
The proportion of subjects with no residual viable tumor cells and negative lymph nodes in the total subjects
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 6 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.
The First Affiliated Hospital,the Air Force Medical University
Xi'an, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cindilimab、IBI310、Capecitabine、Oxaliplatin in people with MSI-H/dMMR Locally Advanced Rectal Adenocarcinoma, run by Xijing 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 19 inclusion and 23 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 6 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response (PCR) rate (time frame: Surgery (within 4-6 weeks of the last administration)). 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 6 Aug 2026.