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Can a Four-Pronged attack shrink rectal tumors enough to skip surgery?

NCT ID NCT07774754

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time

Summary

This phase 2 trial is testing whether adding the immunotherapy drug sintilimab and the anti-angiogenic drug suvemcitug to standard chemoradiation can improve outcomes for people with locally advanced rectal cancer that is microsatellite-stable (pMMR). The study plans to enroll 18 adults aged 18-75 with this type of rectal cancer. Participants will receive radiation plus chemotherapy and immunotherapy, followed by more cycles of chemotherapy, immunotherapy, and the anti-angiogenic drug. The goal is to see if this combination can lead to a complete response, potentially allowing some patients to avoid surgery and instead be monitored closely.

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 the immunotherapy drug sintilimab, the chemotherapy drugs capecitabine and oxaliplatin, the anti-angiogenic drug suvemcitug, and radiation therapy.
What this could lead to
If successful, this approach could increase the chance of a complete response, potentially allowing some patients to avoid surgery and preserve their rectum.
What could go wrong
This is a small, early-phase trial with only 18 participants, so results may not apply broadly. The combination may cause serious side effects, and the added benefit over standard treatment is not yet proven.

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 18 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2031

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 to 75 years

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\) Aged 18-75 years; 2\) ECOG 0-1; 3\) Histologically confirmed rectal adenocarcinoma; 4\) Preoperative staging: cT3-4N0M0 or cT1-4N+M0; 5\) Distance from the tumour's inferior margin to the anus ≤ 12 cm; 6\) Tumour biopsy immunohistochemistry indicates pMMR, i.e. positive expression of all MSH1/MSH2/MSH6/PMS2, and molecular testing indicates MSS (microsatellite-stable). 7\) Haematological parameters: WBC \> 4,000/mm³; PLT \> 100,000/mm³; Hb should, in principle, be \> 10 g/dL; chronic anaemia (haemoglobin \< 10.0 g/dL) is not an exclusion criterion and may be assessed by a multidisciplinary team; 8\) Liver function: Serum total bilirubin ≤ 1.5 × ULN (for subjects with Gilbert's syndrome, total bilirubin ≤ 3 × ULN is allowed);aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; 9\) Renal function: serum creatinine ≤ 1.5 × ULN, or creatinine clearance \> 50 mL/min; 10\) Other: not pregnant or breastfeeding; no other malignant diseases within the past 5 years or concurrently (excluding basal cell carcinoma of the skin or cervical carcinoma in situ); no mental illness preventing the provision of informed consent; no concomitant serious diseases that would shorten survival; 11\) No previous surgery, chemotherapy or radiotherapy for rectal cancer; 12\) No previous immunotherapy; 13\) Previous endocrine therapy: no restrictions. Exclusion Criteria: * 1\) Failure to sign an informed consent form; 2\) Immunohistochemistry of tumor biopsy specimens indicating dMMR or microsatellite instability testing indicating MSI-H; 3\) Preoperative evidence of distant metastasis; 4\) History of severe bleeding tendency or coagulation disorders; patients who have previously or currently require long-term anticoagulant therapy (e.g., patients with atrial fibrillation who have a CHADS2 score of ≥2). 5\) History of myocarditis, cardiomyopathy, or malignant arrhythmias. History of unstable angina, congestive heart failure, or vascular disease (e.g., an aortic aneurysm requiring surgical repair or peripheral venous thrombosis) requiring hospitalization within 12 months prior to study treatment, or other cardiac conditions that may affect the safety evaluation of the study drug (e.g., poorly controlled arrhythmias, myocardial infarction, or ischemia) ; 6\) History of esophageal or fundic varices, severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months prior to study treatment; 7\) History of any arterial thromboembolic event, venous thromboembolism of Grade 3 or higher according to NCI CTCAE Version 5.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 6 months prior to study treatment; 8)An acute exacerbation of chronic obstructive pulmonary disease (COPD) within 1 month prior to study treatment; current hypertension with a systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg despite treatment with oral antihypertensive medications; severe hypertension that is poorly controlled with medication; 9\) History of HIV infection or active chronic hepatitis B or C, or other active, clinically significant infections; 10\) Subjects with active pulmonary tuberculosis (TB) who are currently receiving antituberculosis therapy or who have received such therapy within 1 year prior to screening; 11\) Cachexia, organ dysfunction; 12\) History of pelvic or abdominal radiation therapy; 13\) Multiple primary colorectal cancers; 14\) Patients with seizures requiring treatment (e.g., with steroids or antiepileptic therapy); 15\) History of other malignancies within the past 5 years, excluding cured cervical carcinoma in situ or basal cell carcinoma of the skin; 16\) Substance abuse, or medical, psychological, or social conditions that may interfere with the patient's participation in the study or affect the evaluation of study results; 17\) Known or suspected allergy to the study drug or to any medication administered in connection with this trial; 18\) Any unstable condition or situation that may jeopardize the patient's safety or compliance;Pregnant or breastfeeding women of childbearing potential who are not using adequate contraception.

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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

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.