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Aiming to spare the anus: a new strategy for early rectal cancer

NCT ID NCT06949098

Cure Sponsor: Hebei Medical University Fourth Hospital Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time

Summary

This trial is testing a combination of local tumor removal and chemoradiotherapy (radiation plus capecitabine chemotherapy) in people with early-stage rectal cancer located low in the rectum. The goal is to see if this approach can effectively treat the cancer while avoiding the need for a permanent colostomy, preserving the anus. The study will enroll 60 adults with stage I rectal cancer who strongly prefer to keep their anus. Researchers will track how many patients remain free of cancer recurrence for five years after treatment.

What this could mean

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

Active substance
Local tumor resection followed by chemoradiotherapy (pelvic radiation plus capecitabine chemotherapy)
What this could lead to
If successful, this approach could offer a way to treat early-stage rectal cancer without removing the anus, preserving quality of life.
What could go wrong
This is an early-phase, single-center trial with a small number of patients. The treatment may not control the cancer as well as standard surgery, and there are risks from radiation and chemotherapy.

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 60 people

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

Started

May 2025

Expected to finish

May 2032

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. Age ≥18 years, regardless of gender 2. ECOG performance status 0-1 3. Biopsy-proven rectal adenocarcinoma 4. Distal margin of primary tumor ≤8 cm from anal verge 5. Clinical stage I (cT1-2N0M0) 6. Strong organ preservation preference with refusal to undergo abdominoperineal resection (Miles operation) 7. The surgeon determined a local resection was feasible 8. No contraindications to chemoradiotherapy Exclusion Criteria: 1. Failure to meet the above inclusion criteria 2. Patients refusing to sign informed consent 3. Impaired cognitive function or psychiatric disorders 4. Patients deemed ineligible by investigators

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Conditions

The condition(s) this trial relates to.

rectal cancer rectal carcinoma rectal neoplasm

As listed by the trial registrant

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

Rectal cancer stage I

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 Fourth Hospital of Hebei Medical University

    RECRUITING

    Shijiazhuang, Hebei, China

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