Can drug cocktail spare rectal cancer patients from surgery?
NCT ID NCT07817888
First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time
Summary
Researchers test whether giving mFOLFOXIRI plus bevacizumab before surgery can shrink locally advanced rectal cancer enough to avoid removing the rectum. Adults with stage II or III rectal cancer receive six cycles of the drug combination. Depending on how well the tumor responds, participants may then choose close monitoring, local excision, or standard rectal removal. The trial tracks disease-free survival for three years.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- mFOLFOXIRI plus bevacizumab
- What this could lead to
- If it works, this approach could let some people with locally advanced rectal cancer keep their rectum and avoid major surgery. It may also offer a treatment path that skips radiation.
- What could go wrong
- This is a single-arm phase 2 trial, so it cannot prove the approach is better than standard care. The chemotherapy combination can cause serious side effects, and not everyone's tumor will shrink enough to allow organ preservation.
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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 119 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: * Sign the informed consent form and comply with the planned visits, study treatment, laboratory tests, and other trial procedures; * Age 18-75 years; * Histologically confirmed rectal adenocarcinoma; * The lower edge of the rectal tumor is \<10 cm from the anal verge (as assessed by pelvic MRI); * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; * Willing to choose the "organ preservation" strategy according to the study protocol; * Locally staged as cTNM stage II-III (T3-4 with any N, or any T with N1-2) by contrast-enhanced pelvic MRI; * No prior antitumor therapy for colorectal cancer, including cytotoxic drugs, radiotherapy, molecular targeted therapy, immune checkpoint inhibitors, etc.; * Adequate organ function as indicated by the following laboratory values obtained during the screening period: white blood cell count ≥3×10⁹/L, neutrophil count ≥1.5×10⁹/L, platelet count ≥75×10⁹/L, serum total bilirubin ≤1.5× upper limit of normal (ULN), aspartate aminotransferase or alanine aminotransferase ≤2.5× ULN, serum creatinine ≤1.5× ULN. Exclusion Criteria: * Distant metastasis (M1) confirmed by chest/abdominal/pelvic CT, pelvic MRI, or PET-CT; * Bowel obstruction, active gastrointestinal bleeding, or perforation caused by the tumor; * Tumor complicated by intestinal fistula or pelvic abscess; * Concurrent malignant tumors of other organ systems (except malignancies that have been curatively treated with no recurrence for more than 5 years, or carcinoma in situ that can be cured by adequate treatment); * Thrombotic or embolic events within 12 months prior to enrollment, such as cerebrovascular accident (including transient ischemic attack), pulmonary embolism, or deep vein thrombosis; * Within 12 months prior to enrollment, any of the following: myocardial infarction, severe/unstable angina, New York Heart Association (NYHA) class ≥ II cardiac dysfunction, clinically significant supraventricular or ventricular arrhythmia, and symptomatic congestive heart failure; * Tumors diagnosed as mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H) by immunohistochemistry or PCR; * Uncontrolled systemic infection or unexplained fever (\>38.5°C) within 2 weeks prior to enrollment; * Concurrent presence of any of the following other diseases: human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)-related illness; poorly controlled diseases including but not limited to non-infectious pneumonitis, diabetes mellitus, hypertension, pulmonary fibrosis, acute pneumonia, aneurysm, and coagulation disorders; or any other disease that, in the investigator's opinion, may affect the assessment of study endpoints; * Known or suspected allergy to the study drugs; * Pregnant or lactating women; * Patients with other serious physical or mental illnesses or laboratory abnormalities that may increase the risk of study participation, interfere with study results, or who are considered unsuitable for participation by the investigator.
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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 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.
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Other studies related to the condition(s) this trial covers.
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