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Can a Triple-Drug combo erase rectal tumors before surgery?

NCT ID NCT07750951

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time

Summary

This phase II trial is testing whether giving a combination of two immunotherapies (sintilimab and IBI-310) along with chemotherapy before surgery can improve outcomes for people with a specific type of locally advanced rectal cancer (MSI-H/dMMR). The main goal is to see how often the tumor completely disappears after this pre-surgical treatment. The study will also look at side effects, whether surgery can be less invasive, and long-term survival. About 34 adults with this cancer type will receive the drug combination for six weeks, followed by surgery or close monitoring depending on how well the tumor responds.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A combination of three drugs: sintilimab (an immunotherapy that helps the immune system attack cancer), IBI-310 (another immunotherapy that boosts immune response), and chemotherapy (capecitabine and oxaliplatin).
What this could lead to
If successful, this approach could shrink or eliminate rectal tumors before surgery, potentially allowing some patients to avoid major surgery or preserve their sphincter, improving quality of life.
What could go wrong
This is a small, early-phase study (34 participants), so results may not apply broadly. Immunotherapy and chemotherapy can cause significant side effects, and the treatment may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 34 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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; * 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: 1. The absolute neutrophil count (ANC)≥1.5x109/L without granulocyte colony stimulating factor in the past 14 days; 2. Platelets≥100×109/L without blood transfusion in recent 14 days; 3. Hemoglobin \>9g/dl without blood transfusion or use of erythropoietin in recent 14 days; 4. Total bilirubin ≤ 1.5×upper limit of normal (ULN); 5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤2.5×ULN; 6. Serum creatinine≤1.5×ULN and creatinine clearance (calculated by Cockcroft Gault formula)≥60ml/min; 7. Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT)≤1.5times ULN; 8. 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; 9. 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). Exclusion Criteria: * 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); * 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: 1. 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; 2. 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; 3. 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: a) 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The First Affiliated Hospital,the Air Force Medical University

    RECRUITING

    Xi'an, Shaanxi, 710032, China