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New Pre-Surgery combo aims to shrink rectal tumors and save the rectum

NCT ID NCT07521605

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a new treatment plan for adults with locally advanced rectal cancer that hasn't spread. Participants get a week of radiation, then 8 cycles of three drugs (chemotherapy and immunotherapy) before surgery. The goal is to shrink the tumor enough to cure the cancer or avoid removing the rectum entirely.

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 44 people

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

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Dec 2034

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. Aged 18 to 75 years, male or female. 2. Histologically confirmed diagnosis of rectal adenocarcinoma. 3. Confirmed mismatch repair proficient (pMMR) or microsatellite stable (MSS) status by immunohistochemistry or PCR methods. 4. Locally advanced disease assessed by pelvic MRI, classified as cT3-4aN0M0 or any T stage with node-positive (N+) disease, without distant metastasis (M0), according to the AJCC 8th edition staging system. 5. The lower edge of the tumor is located within 10 cm from the anal verge (defined as low/mid rectal cancer). 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 7. Adequate bone marrow, hepatic, and renal function, defined as: Absolute Neutrophil Count (ANC) ≥ 1.5 x 10⁹/L,Platelet count ≥ 100 x 10⁹/L,Hemoglobin ≥ 90 g/L,Total Bilirubin ≤ 1.5 times the Upper Limit of Normal (ULN),Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 2.5 x ULN,Serum creatinine ≤ 1.5 x ULN or Creatinine Clearance ≥ 50 mL/min (calculated by Cockcroft-Gault formula) 8. Voluntarily participates in the study, signs the informed consent form, demonstrates good compliance, and is able to cooperate with follow-up procedures. Exclusion Criteria: 1. Evidence of distant metastasis (M1 disease) on baseline imaging. 2. Previous radiotherapy to the pelvis, or any prior systemic chemotherapy, targeted therapy, or immunotherapy for colorectal cancer. 3. History of other active malignancies within the past 5 years, except for adequately treated carcinoma in situ of the cervix, basal cell carcinoma of the skin, or other localized tumors considered cured by local treatment. 4. Any of the following uncontrolled conditions or comorbidities: 1)Severe active infection requiring systemic therapy. 2)Unstable angina, myocardial infarction, or congestive heart failure (NYHA Class II-IV) within the last 6 months. 3)Uncontrolled epilepsy, central nervous system disorders, or psychiatric disorders that would compromise the ability to provide informed consent or comply with study procedures. 5\. Known history of severe immunodeficiency or active autoimmune disease requiring systemic immunosuppressive therapy (e.g., corticosteroids at doses \> 10mg/day prednisone equivalent) within the past 2 years. 6\. Known history of hypersensitivity to any component of the study drugs (Liposomal Irinotecan, Capecitabine, Camrelizumab) or history of severe hypersensitivity reactions to other monoclonal antibodies. 7\. Pregnant or lactating women, or subjects of childbearing potential who are unwilling to use highly effective contraception during the study period and for at least 6 months after the last dose of study treatment. 8\. Any other condition or circumstance that, in the opinion of the investigator, would compromise the patient's safety or adherence to the protocol (e.g., inability to swallow oral medications, active gastrointestinal bleeding, intestinal obstruction).

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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

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.