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CRC (Colorectal Cancer)Phase 2NCT07728019

Efficacy and Safety of Retlirafusp Alfa Plus Bevacizumab and Chemotherapy With or Without Short-Course Radiotherapy in Patients With CRCLM

A Phase 2 study testing SCRT, Retlirafusp alfa Injection and Bevacizumab in people with CRC (Colorectal Cancer), run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Efficacy and safety of retlirafusp alfa combined with bevacizumab and chemotherapy with or without short-course radiotherapy in conversion therapy for advanced colorectal cancer liver metastases: an exploratory study. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
CRC (Colorectal Cancer)
What is being tested?
SCRT, Retlirafusp alfa Injection and Bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
30 Jul 2026to 31 Dec 2031
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

  • Provide signed written informed consent and voluntarily agree to participate in this study.
  • Age ≥ 18 years and ≤ 75 years.
  • Histologically confirmed colorectal adenocarcinoma.
  • Liver metastasis confirmed by imaging or pathology.
  • Have not received any prior anti-cancer therapy.
  • At least one measurable lesion according to RECIST v1.1.
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  • pMMR/MSS status confirmed by a local testing center, or unknown status.
  • Be able to swallow tablets.
  • ECOG PS 0-1
  • Have no contraindications for surgery.
  • Have adequate major organ function.

Who cannot join

  • Have a history of allergy to monoclonal antibodies, any component of retlirafusp alfa, bevacizumab, capecitabine, oxaliplatin, or other platinum-based agents.
  • Have previously received or are currently receiving any of the following treatments:
  • Any anti-tumor therapy including surgery, radiotherapy, chemotherapy, targeted therapy, or immunotherapy.
  • 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.
  • Receipt of live attenuated vaccine within 4 weeks prior to the first dose of study drug.
  • Major surgery or severe trauma within 4 weeks prior to the first dose of study drug.
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  • 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.
  • 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.
  • 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.
  • 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).
  • 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.
  • 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).
  • 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.
  • Are pregnant or breastfeeding.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Zhenyu Lin, MD contact

027-83262683

whxhlzy@hust.edu.cn

China1 site, 1 recruiting

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

    Wuhan, Hubei, 430022

    Tao Zhang, MD, 027-85871982, 1277577866@qq.com

    Recruiting

Other trials in China

About this study

Official title: Efficacy and Safety of Retlirafusp Alfa Plus Bevacizumab and Chemotherapy With or Without Short-Course Radiotherapy in Patients With Colorectal Cancer Liver Metastases: a Randomized Phase II Study

Efficacy and safety of retlirafusp alfa combined with bevacizumab and chemotherapy with or without short-course radiotherapy in conversion therapy for advanced colorectal cancer liver metastases: an exploratory study.

Being tested
SCRT, Retlirafusp alfa Injection, Bevacizumab, CAPOX
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SCRTRadiation

    short-course radiotherapy

  • Retlirafusp alfa InjectionDrug

    Retlirafusp alfa :1800 mg via intravenous infusion every 3 weeks (q3w)

  • BevacizumabDrug

    Bevacizumab: 7.5 mg/kg, D1, IV, Q3W

  • CAPOXDrug

    CAPOX:oxaliplatin 130 mg/m²,IV, D1 ; Capecitabine: 1000 mg/m² orally twice daily, Days 1-14; Cycle duration: 3 weeks per cycle

Study groups in NCT07728019
Study groupRoleWhat they receive
SCRT combined with Retlirafusp Alfa Plus Bevacizumab and ChemotherapyExperimentalTotal dose 25 Gy delivered in 5 fractions (5 Gy per fraction, once daily over 5 consecutive days). Retlirafusp alfa plus bevacizumab and capox will recive every 3 weeks, initiated 1 week after radiontherapy completion.
Receives: Radiation: SCRT; Drug: Retlirafusp alfa Injection; Drug: Bevacizumab; Drug: CAPOX
Retlirafusp Alfa combined with Bevacizumab and ChemotherapyExperimentalRetlirafusp alfa plus bevacizumab and capox will recive every 3 weeks
Receives: Drug: Retlirafusp alfa Injection; Drug: Bevacizumab; Drug: CAPOX

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival

    Assessed by the investigator using RECIST v1.1, defined as the time from the start of study treatment to disease progression, or relapse after resection of liver metastases, or death due to any cause.

    Measured: Each follow up visit, assessed up to 60 months

Secondary outcomes (5)

  1. Overall Response Rate

    Partial response (PR) plus complete response (CR)): assessed by the investigator using RECIST v1.1 criteria

    Measured: assessed up to 12 months

  2. R0 Resection Rate

    Defined as the proportion of patients who achieve complete resection after treatment

    Measured: Each follow up visit, assessed up to 12 month

  3. Pathological complete response rate (pCR)

    Pathological complete response rate (pCR) of the resected lesions

    Measured: 2 years after last patient in study

  4. Overall Survival

    Defined as the time from the start of study treatment to death due to any cause

    Measured: Each follow up visit, assessed up to 60 months

  5. Toxicity (AE)

    Patients will be evaluated for Adverse Events at the start of each treatment cycle according to CTCAE version 6.0.

    Measured: 2 years after last patient in study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2026
  2. Study start30 Jul 2026
  3. Primary completion30 Jun 2029 (estimated)
  4. Study completion31 Dec 2031 (estimated)

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07728019
Sponsor's protocol ID
MA-CRC-II-023
Status last verified
Sep 2026
First submitted
22 Jul 2026
Last updated
22 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SCRT, Retlirafusp alfa Injection and Bevacizumab in people with CRC (Colorectal Cancer), run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 11 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: looking for participants now, as of the sponsor's last update on 22 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 Zhenyu Lin, MD (027-83262683, whxhlzy@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (time frame: Each follow up visit, assessed up to 60 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07728019.

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 22 Sep 2026.

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