New combo therapy aims to skip radiation for rectal cancer patients

NCT ID NCT06688786

What the study statuses mean

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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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a new approach for people with locally advanced rectal cancer that has a common genetic profile (MSS/pMMR). Instead of standard radiation before surgery, participants receive a combination of chemotherapy (mFOLFOX6) and an immunotherapy drug (PD-1 antibody). The goal is to shrink the tumor, reduce side effects from radiation, and protect bowel function. About 30 adults aged 18-75 are taking part.

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 30 people

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

Started

Nov 2024

Expected to finish

Dec 2027

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. Advanced (cT3-4NxM0 or cTxN+M0) rectal cancer with the lower tumor margin within 15 cm of the anal verge 2. Histopathology confirmed adenocarcinoma with an pMMR/MSS genetic profile. 3. Absence of bowel obstruction, or bowel obstruction relieved by proximal colostomy. 4. Age: 18-75 5. ECOG: 0-1 6. No prior chemotherapy, radiotherapy, targeted therapy, or immunotherapy received. 7. Female participants must be non-lactating, with a negative pregnancy test result. Exclusion Criteria: 1. Patients with distant metastasis 2. History of receiving chemotherapy, radiotherapy, targeted therapy, or immunotherapy. 3. Active autoimmune disease requiring systemic treatment within the 2 years prior to enrollment. 4. History of other malignancies within the past 5 years, excluding cured cervical carcinoma in situ or basal cell carcinoma of the skin. 5. History of HIV infection, or active chronic hepatitis B or C with high viral DNA copy numbers. 6. Patients with active tuberculosis currently receiving anti-tuberculosis treatment or treated with anti-tuberculosis therapy within the past year prior to screening. 7. Known or suspected allergy to the study drug or any study-related medications administered. 8. Presence of severe cardiovascular or cerebrovascular disease. 9. Within 14 days prior to the first dose, presence of a severe active or uncontrolled infection requiring systemic therapy, or unexplained fever \>38.5°C. 10. Receiving systemic corticosteroid treatment or other immunosuppressive agents within 14 days prior to the first dose, or immunostimulants within 4 weeks. 11. History of confirmed neurological or psychiatric disorders, including epilepsy or dementia. 12. The participant may be unable to complete the study due to other reasons, or the investigator considers them unsuitable for inclusion. 13. Refusal to sign the informed consent form.

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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

  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200092, China

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