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Frozen section could spare rectal cancer patients from major surgery

NCT ID NCT07337811

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This trial is testing whether a quick lab test during surgery can help some people with low rectal cancer avoid a major operation. After radiation therapy, patients with a good response undergo a small local excision. If the frozen section shows no deep cancer, they skip the larger surgery and enter a watch-and-wait program. If cancer is deeper, they get immediate complete removal. The goal is to see if this selective approach keeps cancer under control while reducing complications and preserving quality of life.

What this could mean

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

Active substance
Selective total mesorectal excision based on intra-operative frozen section
What this could lead to
If successful, this approach could allow many patients with low rectal cancer to avoid major surgery and a permanent colostomy, preserving bowel function and quality of life.
What could go wrong
This is a small, early-phase trial with only 27 participants, so results may not apply broadly. There is a risk that the frozen-section analysis may miss cancer cells, leading to undertreatment or recurrence.

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

About 27 people

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

Started

Aug 2025

Expected to finish

Jul 2028

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. Pathologically confirmed rectal adenocarcinoma. 2. Neoadjuvant therapy based on radiotherapy; post-radiotherapy evaluation ≥8 weeks later shows near clinical complete response (near-cCR) or partial response (PR) with residual tumor \<2 cm. 3. Tumor distance from the anal verge ≤5 cm. 4. Age 18-75 years. 5. No synchronous multiple primary cancers. 6. No contraindications to pre-operative radiotherapy or chemotherapy. 7. Adequate organ function (cardiac, hepatic, renal, hematologic). 8. Patient or legally authorized representative able to understand the study protocol, willing to participate, and provide written informed consent. Exclusion Criteria: 1. Age \<18 or \>75 years. 2. Concurrent or previous malignancy within the past 5 years (except adequately treated basal-cell or squamous-cell skin carcinoma or carcinoma in situ of the cervix). 3. Emergency surgery required for bowel obstruction, perforation, or bleeding. 4. Prior colorectal surgery that may compromise intestinal reconstruction. 5. Need for en-bloc multivisceral resection. 6. ASA physical status IV or V. 7. Pregnant or lactating women. 8. a) Women of child-bearing potential with a positive serum pregnancy test at baseline or who have not undergone pregnancy testing; post-menopausal women must have been amenorrheic for ≥12 months. 9. b) Men or women of reproductive potential unwilling to use effective contraception throughout the study period. 10. Severe psychiatric illness precluding informed consent or compliance. 11. Severe COPD, interstitial lung disease, or ischemic heart disease precluding safe surgery. 12. Continuous systemic corticosteroid therapy within 1 month before enrolment. 13. Contraindications to laparoscopic surgery. 14. Patient or legally authorized representative unable to understand the study conditions and objectives.

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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

  • Dept. of Colorectal Surgery, Sun Yat-sen University Cancer Center. Yuexiu District, Dongfeng East Road 651

    RECRUITING

    Guangzhou, Guanggong, 510060, China

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