Can a new drug combo shrink liver tumors in Hard-to-Treat colorectal cancer?
NCT ID NCT07797244
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 46 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Chinese PLA General Hospital, Beijing
Beijing, Beijing Municipality, 100142, China