ClinicalTrials.gg
RecruitingNCT07728019Updated Sep 22, 2026

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

A Phase 2 interventional study of SCRT and Retlirafusp alfa Injection in CRC (Colorectal Cancer), sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2026; still recruiting 3 months later.

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Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 230 studies testing bevacizumab in Colorectal Neoplasms — 49 open to participants now, 61 under way, 11 of them phase 3. Bevacizumab · Colorectal Neoplasms.

Planned enrollment
115th of 224
60 · median 63
Started
2026
with 12 others
Phase 2
133 of 230
31 open now
Primary completion
2029-06
later than 54 of 60 live
Registered
229th of 230
by date

Among the 230 studies testing bevacizumab in Colorectal Neoplasms, this one is the 115th largest by planned enrollment of the 224 interventional ones that give a count, is one of 13 that started in 2026, is one of 133 in phase 2, reaches primary completion later than 54 of the 60 other live ones, and was the 229th registered.

Colorectal Neoplasms

6,545 studies on the registry are indexed under Colorectal Neoplasms; 1,664 are open to participants now.

Browse Colorectal Neoplasms studies →

Open to participants now

49 of the 230 studies testing bevacizumab in Colorectal Neoplasms are open now, in 12 countries. Recruiting first, the newest first:

43 more — sign in →

By country, each count listing its studies:

All 49 open studies →

About bevacizumab

Bevacizumab: first FDA approval 2004 (AVASTIN), first EMA approval 2005. What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 1,181 Colorectal Neoplasms studies recruiting now, 764 (65%) set no upper age limit and 264 (22%) stop at 75 or younger; 48 take children under 18; 123 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 230 studies testing bevacizumab in Colorectal Neoplasms, or all of them as a file.
02

Study 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.

03

Conditions studied

  • CRC (Colorectal Cancer)
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Provide signed written and voluntarily agree to participate in this study.
  2. Age ≥ 18 years and ≤ 75 years.
  3. confirmed colorectal adenocarcinoma.
  4. Liver confirmed by imaging or pathology.
  5. Have not received any prior anti-cancer therapy.
  6. At least one according to v1.1.
  7. pMMR/MSS status confirmed by a local testing center, or unknown status.
  8. Be able to swallow tablets.
  9. PS 0-1
  10. Have no for surgery.
  11. Have adequate major organ function.

Exclusion criteria

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 agents or systemic 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 disease.
    3. Receipt of 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 -positive test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation or bone marrow transplantation.
  5. Have poorly controlled cardiac symptoms or diseases, including but not limited to: (1) heart failure of (NYHA) class ≥ II; (2) unstable angina; (3) myocardial infarction within 1 year; (4) supraventricular or ventricular arrhythmias that have not been clinically intervened or remain poorly controlled after intervention.
  6. Have experienced a severe infection ( 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 (HBV DNA ≥ 2000 IU/mL or ≥ 10⁴ copies/mL), or (positive anti-HCV antibody and HCV RNA above the lower limit of detection of the assay).
  9. Have been diagnosed with another within 5 years prior to the first dose of study drug, except for malignancies with a low risk of 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.
Terms in these criteria, in plain language(19)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

CTCAE grade

The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    SCRT combined with Retlirafusp Alfa Plus Bevacizumab and Chemotherapy

    Total 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.

    Radiation: SCRT · Drug: Retlirafusp alfa Injection · Drug: Bevacizumab · Drug: CAPOX

  • Experimental
    Retlirafusp Alfa combined with Bevacizumab and Chemotherapy

    Retlirafusp alfa plus bevacizumab and capox will recive every 3 weeks

    Drug: Retlirafusp alfa Injection · Drug: Bevacizumab · Drug: CAPOX

Interventions

  • RadiationSCRT

    short-course radiotherapy

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

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

  • DrugCAPOX

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

06

What researchers measure

Primary outcomes

  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.

    Time frame: Each follow up visit, assessed up to 60 months

Secondary outcomes

  1. Overall Response Rate

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

    Time frame: assessed up to 12 months

  2. R0 Resection Rate

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

    Time frame: Each follow up visit, assessed up to 12 month

  3. Pathological complete response rate (pCR)

    Pathological complete response rate (pCR) of the resected lesions

    Time frame: 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

    Time frame: 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.

    Time frame: 2 years after last patient in study

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2026 (actual). Primary completion is estimated for Jun 2029, 35 months after the start.

Of 498 non-industry phase 2 interventional studies under Colorectal Neoplasms, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 75. This study's planned 35 months is below that.

Counting every sponsor, half of 618 studies reached it within 49 months; a quarter within 31 and three quarters within 75.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 22, 2026
First posted
Jul 27, 2026
StartActual
Jul 30, 2026
Primary completionEst.
Jun 30, 2029
CompletionEst.
Dec 31, 2031
Last update
Sep 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07728019
Responsible party
Tao Zhang (MD, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology) — Principal investigator
First posted
Jul 27, 2026
Start date
Jul 30, 2026
Primary completion
Jun 30, 2029 (estimated)
Completion
Dec 31, 2031 (estimated)
Last update
Sep 22, 2026

Study contacts

Zhenyu Lin, MD
Contact
whxhlzy@hust.edu.cn
027-83262683
Tao Zhang, MD
principal investigator · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Kaixiong Tao, MD
principal investigator · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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