Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Can a four-pronged attack shrink liver tumors enough for surgery?

NCT ID NCT07728019

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 27, 2026 · Last updated Jul 28, 2026 · Updated 1 time

Summary

This phase II trial is testing whether adding an experimental drug called retlirafusp alfa to standard chemotherapy and bevacizumab, with or without a short course of radiotherapy, can shrink liver metastases from colorectal cancer enough to allow surgical removal. The study enrolls adults aged 18 to 75 with previously untreated colorectal cancer that has spread to the liver. The goal is to see if this combination improves progression-free survival and increases the chance of complete tumor removal.

What this could mean

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

Active substance
retlirafusp alfa combined with bevacizumab and chemotherapy, with or without short-course radiotherapy
What this could lead to
If successful, this combination could shrink liver metastases enough to allow surgical removal, potentially improving long-term outcomes for people with advanced colorectal cancer.
What could go wrong
This is an early-phase trial with only 60 participants, so results may not apply broadly. Combining multiple treatments also raises the risk of serious side effects.

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 60 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2031

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. Provide signed written informed consent and voluntarily agree to participate in this study. 2. Age ≥ 18 years and ≤ 75 years. 3. Histologically confirmed colorectal adenocarcinoma. 4. Liver metastasis confirmed by imaging or pathology. 5. Have not received any prior anti-cancer therapy. 6. At least one measurable lesion according to RECIST v1.1. 7. pMMR/MSS status confirmed by a local testing center, or unknown status. 8. Be able to swallow tablets. 9. ECOG PS 0-1 10. Have no contraindications for surgery. 11. Have adequate major organ function. Exclusion Criteria: 1. Have a history of allergy to monoclonal antibodies, any component of retlirafusp alfa, bevacizumab, capecitabine, oxaliplatin, or other platinum-based agents. 2. Have previously received or are currently receiving any of the following treatments: 1. Any anti-tumor therapy including surgery, radiotherapy, chemotherapy, targeted therapy, or immunotherapy. 2. Use of immunosuppressive agents or systemic corticosteroids for immunosuppressive purposes within 2 weeks prior to the first dose of study drug (at a dose \> 10 mg/day prednisone or equivalent). Inhaled or topical corticosteroids, and adrenal replacement therapy at doses \> 10 mg/day prednisone or equivalent, are permitted in the absence of active autoimmune disease. 3. Receipt of live attenuated vaccine within 4 weeks prior to the first dose of study drug. 4. Major surgery or severe trauma within 4 weeks prior to the first dose of study drug. 3. Have any active autoimmune disease or history of autoimmune disease, including but not limited to interstitial pneumonitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, or hypothyroidism (patients on hormone replacement therapy may be considered for inclusion). Patients with psoriasis or childhood asthma/allergy that has completely resolved and requires no intervention in adulthood may be considered for inclusion, but those requiring medical intervention with bronchodilators are not eligible. 4. Have a history of immunodeficiency, including HIV-positive test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation. 5. Have poorly controlled cardiac symptoms or diseases, including but not limited to: (1) heart failure of New York Heart Association (NYHA) class ≥ II; (2) unstable angina; (3) myocardial infarction within 1 year; (4) clinically significant supraventricular or ventricular arrhythmias that have not been clinically intervened or remain poorly controlled after intervention. 6. Have experienced a severe infection (CTCAE grade \> 2) within 4 weeks prior to the first dose of study drug, such as severe pneumonia requiring hospitalization, bacteremia, or infectious complications; or have evidence of active pulmonary inflammation on baseline chest imaging, or have signs/symptoms of infection or require oral or intravenous antibiotic therapy within 14 days prior to the first dose of study drug (except for prophylactic antibiotic use). 7. Have active pulmonary tuberculosis infection by history or CT examination, or a history of active pulmonary tuberculosis infection within 1 year prior to enrollment, or a history of active pulmonary tuberculosis infection \> 1 year ago without adequate treatment. 8. Have hepatitis B (HBV DNA ≥ 2000 IU/mL or ≥ 10⁴ copies/mL), or hepatitis C (positive anti-HCV antibody and HCV RNA above the lower limit of detection of the assay). 9. Have been diagnosed with another malignancy within 5 years prior to the first dose of study drug, except for malignancies with a low risk of metastasis or death (5-year survival rate \> 90%), such as adequately treated basal cell carcinoma or squamous cell skin cancer, or cervical carcinoma in situ, which may be considered for inclusion. 10. Are pregnant or breastfeeding.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Colorectal adenocarcinoma with liver metastases are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

  • Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430022, China

More trials for these conditions

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