Advanced RAS-Mutated Colorectal Cancer With Liver Metastases (CRLM)Phase 2NCT07797244
A Single-Arm, Phase II Study of Retlirafusp Alfa in Combination With XELOX and Bevacizumab for the First-Line Treatment of Advanced RAS-Mutated Colorectal Cancer With Liver Metastases (CRLM)
A Phase 2 study testing Retlirafusp alfa+XELOX+Bevacizumab Treatment in people with Advanced RAS-Mutated Colorectal Cancer With Liver Metastases (CRLM), run by Dai, Guanghai at 1 site in China.
Trial summary
This single-arm phase II trial enrolls patients with RAS-mutant, microsatellite-stable (MSS) unresectable colorectal cancer liver metastases receiving first-line treatment with Retlirafusp alfa combined with XELOX (capecitabine plus oxaliplatin) and bevacizumab. The primary endpoint is objective response rate (ORR). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced RAS-Mutated Colorectal Cancer With Liver Metastases (CRLM)
- What is being tested?
- Retlirafusp alfa+XELOX+Bevacizumab Treatment
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 29 Oct 2026to Oct 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-75 years;
- Unresectable colorectal adenocarcinoma confirmed by histopathology or cytology;
- MSS/pMMR;
- RAS-mutant;
- ECOG PS score of 0-1;
- No prior systemic treatment;
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- At least one measurable liver metastasis;
- Expected survival of ≥3 months;
- 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);
- Participants voluntarily enroll in this study, sign an informed consent form, demonstrate good compliance, and cooperate with follow-up;
- The investigator believes the participant may benefit from treatment.
Who cannot join
- History of or concurrent other malignant tumors, excluding cured basal cell carcinoma of the skin and cervical carcinoma in situ;
- 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;
- Presence of active infections (e.g., sepsis, active tuberculosis) or uncontrolled autoimmune diseases;
- 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;
- History of active cirrhosis, uncontrolled comorbidities, chronic myopathy, active hepatitis, or persistent unexplained elevation of serum transaminases;
- 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;
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- Allergy to or contraindications for the study drug;
- 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;
- 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;
- History of thyroid dysfunction, where thyroid function cannot be maintained within the normal range even with medication;
- 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;
- 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);
- 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);
- Patients deemed unsuitable for inclusion in this study by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Chinese PLA General Hospital, Beijing
Beijing, Beijing Municipality, 100142
Guanghai Dai, MD, 01066947252, daigh301@vip.sina.com
About this study
This single-arm phase II trial enrolls patients with RAS-mutant, microsatellite-stable (MSS) unresectable colorectal cancer liver metastases receiving first-line treatment with Retlirafusp alfa combined with XELOX (capecitabine plus oxaliplatin) and bevacizumab. The primary endpoint is objective response rate (ORR). A total of 46 patients will be enrolled, and the study is expected to be completed between 2026 and 2029.
- Being tested
- Retlirafusp alfa+XELOX+Bevacizumab Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retlirafusp alfa+XELOX+Bevacizumab TreatmentDrug
Enrolled subjects received Retlirafusp alfa injection (1800 mg, IV, Day 1, every 3 weeks) + bevacizumab (7.5 mg/kg, IV, Day 1, every 3 weeks) plus XELOX (capecitabine 1,000 mg/m², oral, twice daily, Days 1-14; and oxaliplatin 130 mg/m², IV, Day 1, every 3 weeks). Oxaliplatin was discontinued after a maximum of 8 cycles, while the other agents were continued, marking the transition to the maintenance phase. Immunotherapy was administered for no more than 2 years.
| Study group | Role | What they receive |
|---|---|---|
| The Retlirafusp alfa in combination with XELOX and bevacizumab treatment group | Experimental | Not described Receives: Drug: Retlirafusp alfa+XELOX+Bevacizumab Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
The proportion of patients with a confirmed complete response or partial response
Measured: 24 months
Secondary outcomes (3)
Progress-free Survival(PFS)
The time from enrollment until tumor progression or death from any cause, whichever occurred first
Measured: 24 months
Overall Survival (OS)
The time from randomization to death from any reason
Measured: 24 months
Incidence of Adverse Events
Incidence of Adverse Events According to the CTCAE 6.0
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start29 Oct 2026 (estimated)
- Primary completionApr 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced RAS-Mutated Colorectal Cancer With Liver Metastases (CRLM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dai, Guanghai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dai, Guanghai, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07797244
- Sponsor's protocol ID
- S2026-512-01
- Status last verified
- Aug 2026
- First submitted
- 28 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Phase II Study of Retlirafusp Alfa in Combination With XELOX and Bevacizumab for the First-Line Treatment of Advanced RAS-Mutated Colorectal Cancer With Liver Metastases (CRLM)
- ClinicalTrials.gov ID
- NCT07797244
- Acronym / sponsor ID
- S2026-512-01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Dai, GuanghaiUniversity, hospital or other
- Study start
- 29 Oct 2026 (estimated)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single-arm phase II trial enrolls patients with RAS-mutant, microsatellite-stable (MSS) unresectable colorectal cancer liver metastases receiving first-line treatment with Retlirafusp alfa combined with XELOX (capecitabine plus oxaliplatin) and bevacizumab. The primary endpoint is objective response rate (ORR). A total of 46 patients will be enrolled, and the study is expected to be completed between 2026 and 2029.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The Retlirafusp alfa in combination with XELOX and bevacizumab treatment group | Experimental | Drug: Retlirafusp alfa+XELOX+Bevacizumab Treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age: 18-75 years;
- Unresectable colorectal adenocarcinoma confirmed by histopathology or cytology;
- MSS/pMMR;
- RAS-mutant;
- ECOG PS score of 0-1;
Key exclusion criteria (14 listed)
- History of or concurrent other malignant tumors, excluding cured basal cell carcinoma of the skin and cervical carcinoma in situ;
- 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;
- Presence of active infections (e.g., sepsis, active tuberculosis) or uncontrolled autoimmune diseases;
- 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;
- History of active cirrhosis, uncontrolled comorbidities, chronic myopathy, active hepatitis, or persistent unexplained elevation of serum transaminases;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retlirafusp alfa+XELOX+Bevacizumab TreatmentEnrolled subjects received Retlirafusp alfa injection (1800 mg, IV, Day 1, every 3 weeks) + bevacizumab (7.5 mg/kg, IV, Day 1, every 3 weeks) plus XELOX (capecitabine 1,000 mg/m², oral, twice daily, Days 1-14; and oxaliplatin 130 mg/m², IV, Day 1, every 3 weeks). Oxaliplatin was discontinued after a maximum of 8 cycles, while the other agents were continued, marking the transition to the maintenance phase. Immunotherapy was administered for no more than 2 years. | Drug | The Retlirafusp alfa in combination with XELOX and bevacizumab treatment group |
Primary outcome
Objective response rate (ORR)
Time frame: 24 months
The proportion of patients with a confirmed complete response or partial response
3 secondary outcomes
Progress-free Survival(PFS)
Time frame: 24 months
Overall Survival (OS)
Time frame: 24 months
Incidence of Adverse Events
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Retlirafusp alfa+XELOX+Bevacizumab Treatment in people with Advanced RAS-Mutated Colorectal Cancer With Liver Metastases (CRLM), run by Dai, Guanghai at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guanghai Dai, MD (01066947252, daigh301@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.