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New drug combo aims to shrink rectal tumors before surgery

NCT ID NCT07454720

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 adding two drugs (adebrelimab and SHR-8068) to standard chemoradiation helps shrink advanced rectal cancer before surgery. About 165 adults aged 18-75 with resectable tumors will participate. The goal is to see if more patients achieve a complete response (no cancer detectable) after treatment.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 165 people

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

Started

Mar 2026

Expected to finish

Nov 2035

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form. 2. Male or female ≥ 18 years old and ≤75 years old. 3. ECOG performance status of 0-1. 4. An assessment of resectable locally advanced rectal. 5. Has not received any anti-tumor treatment for rectal cancer. 6. With a life expectancy of ≥2 years. 7. Male participants whose partners are fertile women and fertile female participants must take effective contraceptive measures together with their partners from the time of signing the informed consent form until 6 months after the last administration of the investigational drug or the last radiotherapy. Female participants with fertility must have a negative serum or urine test for human chorionic gonadotropin (HCG) within 7 days before the first administration of the drug (if the serum HCG test is positive, pregnancy should be ruled out and further discussion with the sponsor should be conducted), and they must be not in the lactation period. Exclusion Criteria: 1. Patients with rectal cancer who have experienced local recurrence after previous treatment. 2. Patients with concurrent colon tumors. 3. Patients with initially unresectable colorectal cancer as evaluated by researchers or those whose condition is determined by researchers to be intolerant to surgery. 4. Clinical or imaging examinations suggest the presence of intestinal obstruction or perforation, or those assessed by researchers as having a relatively high risk of perforation or bleeding. 5. With distant metastases. 6. Imaging examination of rectal cancer indicated positive lateral lymph nodes. 7. Having received surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc. for tumors. 8. Female participants who are pregnant, breastfeeding or planning to become pregnant during the study period. 9. There are uncontrollable mental illnesses and other circumstances known to affect the completion of the research procedures, such as alcohol abuse, drug abuse or drug abuse, and criminal detention. 10. Any other factors that may increase the risk of participating in the study, interfere with the study results, or make participation in the study inappropriate as judged by investigators.

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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

    2 sites. 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

  • Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

    RECRUITING

    Wuhan, Hubei, 430022, China

  • Zhejiang Cancer Hospital

    RECRUITING

    Hangzhou, Zhejiang, 310022, China