Can a Four-Pronged attack shrink rectal tumors enough to skip surgery?
NCT ID NCT07774754
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 18 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2031
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
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Other studies related to the condition(s) this trial covers.
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- Can two immunotherapy drugs help rectal cancer patients skip pelvic radiation?
- Can digital surveys capture the full toll of rectal cancer treatment?
- Can a targeted drug conjugate outsmart advanced colorectal cancer?
- Can a platform trial match the right drug combo to each tumor?