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New combo attack on rectal cancer: chemo plus targeted surgery shows promise

NCT ID NCT06048146

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at 180 people with rectal cancer that had spread to lymph nodes in the pelvis. One group received a three-drug chemotherapy regimen (FOLFOXIRI) followed by surgery to remove the affected lymph nodes. The other group got standard chemoradiotherapy before surgery. The goal was to see if the new approach improves how long people live without the cancer coming back. The trial is complete, and results will help determine if this more intensive treatment is worth the extra side effects.

What this could mean

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

Active substance
FOLFOXIRI (irinotecan, oxaliplatin, 5-fluorouracil) and lateral lymph node dissection
What this could lead to
If successful, this approach could improve survival and reduce cancer recurrence for people with rectal cancer that has spread to nearby lymph nodes.
What could go wrong
This is a completed study with 180 participants, but results are not yet widely confirmed. The three-drug chemo regimen has higher side effects, and the surgery adds risks. Further research is needed to see if it truly beats standard care.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

180 people

The number who actually took part.

Started

Oct 2022

Finished

Dec 2025

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 70 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: * Age 18-70 years old, gender is not limited; * The clinical stage based on magnetic resonance imaging (MRI) is cT1-4aN+M0 (according to AJCC Cancer Staging Manual, 8th Edition, 2018). * Meet the criteria for lateral lymph node metastasis (lymph node short diameter ≥7mm, or lymph node short diameter ≥5cm with uneven internal signals and no chemical shift effect, or irregular boundaries); * The primary tumor was located in the rectum (hard tube proctoscopy indicated that the lower margin of the lesion was less than 10cm from the anus); * Kastler score ≥70, ECOG score 0 or 1; * Meet the following laboratory diagnostic indicators: hemoglobin ≥100g/L, white blood cells ≥3.5×109 /L, neutrophil ≥1.5×109/L, platelet ≥100×109/L; Creatinine ≤1.5× upper limit of normal (UNL); Urea nitrogen (BUN) ≤1.5 upper limit of normal (UNL) alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤2.5×UNL, alkaline phosphatase (ALP) ≤2.5×UNL, total bilirubin (Tbil) ≤2.5×UNL; Urinary protein (-); Clotting time is normal. * Patients with primary locally advanced rectal cancer required that they had not received surgery, radiotherapy, chemotherapy or other antitumor therapy from diagnosis to enrollment; No previous pelvic radiation; * Subjects voluntarily join the study and sign the informed consent. Exclusion Criteria: * A history of malignancy at other sites, excluding curable non-melanic skin cancer and carcinoma in situ of the cervix; * Unable to complete MRI; * Preoperative examination indicated the need for combined organ resection; * Allergic to 5-Fu and platinum drugs; Inability to swallow oral medications; * The patient is under thrombolytic or anticoagulant therapy, has bleeding diathesis or coagulation dysfunction, or has occurred in the past year Aneurysm, stroke, transient ischemic attack, arteriovenous malformation; * After renal history, urine test found proteinuria or clinical renal function was obviously abnormal; * History of digestive tract fistula, perforation or severe ulcer; * Active infection is present; Clinically significant cardiac disease (e.g., uncontrolled hypertension (160/110) mm Hg blood pressure, any history of myocardial infarction, unstable angina), NYHA class Ⅱ congestive heart failure, unstable symptomatic arrhythmias, or class II peripheral vascular disease. Myocardial infarction and cerebrovascular accident occurred within 6 months before enrollment; * Participating in other clinical trials currently or within 4 weeks prior to enrollment; * long-term adverse drug history, drug addiction history of mental disorders; * Other cases where the examiner considers from the registration study that there are good reasons for non-conformity: if there are potential inconsistencies with the clinical protocol.

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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.

Contacts and locations

Locations

  • Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College

    Beijing, Beijing Municipality, 100021, China

More trials for these conditions

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