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Rectal cancer breakthrough: immunotherapy may replace surgery for some

NCT ID NCT04643041

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests whether patients with a specific type of rectal cancer (dMMR/MSI-H) can safely avoid surgery after immunotherapy. After six rounds of a PD-1 inhibitor, those whose tumors completely disappear will be monitored closely instead of undergoing standard treatments. The goal is to preserve bowel and sexual function while keeping the cancer from returning.

What this could mean

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

Active substance
PD-1 monoclonal antibody (immunotherapy)
What this could lead to
If successful, this could allow some rectal cancer patients to skip surgery and its side effects, relying on immunotherapy alone to keep the cancer away.
What could go wrong
This is a small, early-phase study with only 47 participants. The cancer may return, and immunotherapy can cause serious side effects. Results may not apply to all patients.

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 47 people

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

Started

Jan 2021

Expected to finish

Dec 2026

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 80 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: Preliminary inclusion criteria: * Histological identified rectal adenocarcinoma, * Tumor biopsy immunohistochemical (IHC) identified dMMR, including one or more deficient of the MSH1,MSH2,MSH6 and PMS2 protein expression and diagnosed as deficient mismatch repair(dMMR), or next generation sequencing identified (MSI-H); MRI identified tumor inferior margin lower than peritoneal reflection, * Clinical staging TxNxM0, with or without positive MRF, with or without positive EMVI, * Staging method:all patients undergo rectal palpation, high resolution MRI ± transrectal Ultrasound examination,positive perienteric lymph node(LN): short diameter ≥10mm LN or LN with typical metastatic shape and MRI character, clinical data should be re-evaluated and judged by center evaluation group when there are contradictory stagings,distant metastasis were excluded by chest and abdominal enhanced CT and pelvic enhanced MRI, * No intestinal obstruction symptom,or obstruction relieved after proximal colostomy, * No rectal surgery history, * No chemotherapy or radiotherapy history, * No biopharmaceutical treatment history(such as monoclonal antibody), immunotherapy(such as anti PD-1antibody, anti PD-L1 antibody, anti PD-L2 antibody or anti CTLA-4), or other research drug treatment, * Endocrinotherapy history restriction:No * Informed consent assigned, Final inclusion criteria: * Clinical complete response (cCR)(Chest,abdominal and pelvic enhanced CT or pelvic enhanced MRI or transrectal ultrasound proved) * Transrectal ultrasound biopsy or endoscopic biopsy proved pathologically complete response (pCR) Exclusion Criteria: * Arrhythmia need anti-arrhythmia treatment(except β-blocking agent or Digoxin),symptomatic coronary heart disease or myocardial ischemia(myocardial infarction within 6 months) or congestive heart-failure (CHF) \> NYHA grade II, * Severe hypertension not well controlled by drugs, * HIV infection history or active phase of chronic Hepatitis B or C(high copies of virus DNA), * Active tuberculosis(TB),accepting anti-TB treatment or anti-TB treatment within 1 year before trial screen, * Other active clinical severe infection(NCI-CTC V5.0), * Outside pelvic distant metastasis evidences, * Dyscrasia, organ dysfunction, * Pelvic or abdominal radiotherapy history, * Multiple CRC or Multi-primary tumors; * Epilepsy need treatments(Steroid or anti-epilepsy therapy), * Other malignant tumor history within 5 years, * Over abuse of drugs, medical and psychological or social conditions that might interfere patients or evaluation of the study results, * Any active autoimmune disease or autoimmune disease history (including but not restricted:interstitial pneumonia, uveitis,enteritis, hepatitis,hypophysitis, nephritis, hyperthyroidism, hypothyroidism, asthma need bronchodilators), * Any anti-infection vaccine injection 4 weeks before inclusion , * Long-term exposure to immune-suppressor, combination of systemic or topical use of corticosteroids (dose\>10mg/day prednisolone or equivalent hormone); * Known or suspicious allergy to any study related drugs, * Any unstable state might cause damage to the safety and compliance of patients, * Pregnant or breast feeding women who has ability to have children while without contraception, * Refuse to sign informed consent

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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

  • Sun Yatsen University

    RECRUITING

    Guangzhou, Guangdong, China

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