Can a new drug combo shrink liver tumors in Hard-to-Treat colorectal cancer?

NCT ID NCT07797244

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time

Summary

This phase II trial tests whether adding retlirafusp alfa to standard chemotherapy and bevacizumab can shrink tumors in people with advanced RAS-mutated colorectal cancer that has spread to the liver. The study enrolls 46 adults who have not had prior systemic treatment and whose tumors are microsatellite-stable. Researchers measure how many patients respond to the treatment, how long they live without the cancer progressing, and what side effects occur.

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 XELOX chemotherapy (capecitabine and oxaliplatin) and bevacizumab
What this could lead to
If it works, this combination could become a new first-line treatment option for people with RAS-mutated colorectal cancer that has spread to the liver, potentially shrinking tumors and extending life.
What could go wrong
This is a small, single-arm phase II trial, so results may not hold up in larger studies. The treatment may cause side effects from chemotherapy and immunotherapy, and it may not improve outcomes for 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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 46 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Oct 2029

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. Age: 18-75 years; 2. Unresectable colorectal adenocarcinoma confirmed by histopathology or cytology; 3. MSS/pMMR; 4. RAS-mutant; 5. ECOG PS score of 0-1; 6. No prior systemic treatment; 7. At least one measurable liver metastasis; 8. Expected survival of ≥3 months; 9. Normal function of major organs; no severe abnormalities in hematological, cardiac, pulmonary, hepatic, renal, or bone marrow function; and no immunodeficiency. Laboratory test results must meet the following requirements: ① Hemoglobin (Hb) ≥90 g/L; ② White blood cell (WBC) count ≥ 3.0 × 10⁹/L; neutrophil count (NEUT) ≥ 1.5 × 10⁹/L; ③ Platelet (PLT) count ≥ 100 × 10⁹/L ④ Renal function (serum creatinine, sCr) ≤ 1.5 times the upper limit of normal (ULN); ⑤ Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); 10. Participants voluntarily enroll in this study, sign an informed consent form, demonstrate good compliance, and cooperate with follow-up; 11. The investigator believes the participant may benefit from treatment. Exclusion Criteria: 1. History of or concurrent other malignant tumors, excluding cured basal cell carcinoma of the skin and cervical carcinoma in situ; 2. History of severe cardiovascular disease, such as congestive heart failure (New York Heart Association Class III-IV), myocardial infarction within the past 6 months, unstable angina, or severe arrhythmias; 3. Presence of active infections (e.g., sepsis, active tuberculosis) or uncontrolled autoimmune diseases; 4. History of severe gastrointestinal diseases, such as active peptic ulcers, intestinal obstruction, or gastrointestinal bleeding, which may affect drug absorption or increase treatment-related risks; 5. History of active cirrhosis, uncontrolled comorbidities, chronic myopathy, active hepatitis, or persistent unexplained elevation of serum transaminases; 6. Coagulation disorders with a tendency to bleed (must meet the following criterion 14 days prior to enrollment: INR within the normal range without the use of anticoagulants); Subjects receiving treatment with anticoagulants or vitamin K antagonists, such as warfarin, heparin, or their analogs; low-dose warfarin (1 mg orally once daily) or low-dose aspirin (daily dose not exceeding 100 mg) is permitted for prophylactic purposes, provided that the International Normalized Ratio (INR) of prothrombin time is ≤ 1.5; 7. Allergy to or contraindications for the study drug; 8. Pregnant or breastfeeding women, or patients planning to become pregnant during the study or within 6 months after the study ends and who are not using effective contraception; 9. Presence of other serious, uncontrolled medical conditions or psychiatric disorders that may affect the patient's ability to participate in the study or undergo evaluation; 10. History of thyroid dysfunction, where thyroid function cannot be maintained within the normal range even with medication; 11. Patients with severe, uncontrolled hypertension (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 90 mmHg despite antihypertensive medication), or a history of hypertensive crisis or hypertensive encephalopathy; 12. Patients with a history of severe bleeding or a high risk of bleeding, including but not limited to: clinically significant bleeding (e.g., ≥ Grade 2 gastrointestinal bleeding) occurring within 3 months prior to the first administration of the study drug; active hemoptysis (hemoptysis volume ≥ half a teaspoon, approximately 2.5 mL of fresh blood, within the past month); imaging evidence of tumor invasion of major blood vessels; or an untreated coagulation disorder (however, patients receiving a stable dose of anticoagulant therapy with an INR within the therapeutic range may be considered for enrollment following the investigator's assessment); 13. Patients who have experienced the following arterial or venous thromboembolic events within 6 months prior to the first administration of the study drug: cerebrovascular accident (including ischemic stroke and transient ischemic attack), myocardial infarction, acute coronary syndrome, uncontrolled deep vein thrombosis, or pulmonary embolism (superficial venous thrombosis, such as PICC-related upper extremity venous thrombosis, may be considered on a case-by-case basis if assessed by the investigator as low risk); 14. Patients deemed unsuitable for inclusion in this study by the investigator.

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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

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Contacts and locations

Locations

  • Chinese PLA General Hospital, Beijing

    Beijing, Beijing Municipality, 100142, China