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AzTrials

Colorectal Cancer With Liver MetastasisPhase 2NCT06972498

A Prospective Multicenter Study: Ivosimab + Chemotherapy as Neoadjuvant for Resectable pMMR/MSS CRC Liver Mets

A Phase 2 study testing Patients will receive ivosimab combined with the XELOX/FOLFOX regimen, followed by radical surgery 4-6 weeks after the last dose; adjuvant chemotherapy will continue for 3 months postoperatively. in people with Colorectal Cancer With Liver Metastasis, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The population receiving ivosimab combined with chemotherapy for neoadjuvant treatment of colorectal cancer liver metastasis. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Colorectal Cancer With Liver Metastasis
What is being tested?
Patients will receive ivosimab combined with the XELOX/FOLFOX regimen, followed by radical surgery 4-6 weeks after the last dose; adjuvant chemotherapy will continue for 3 months postoperatively.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
No sites listed yet
Study dates
1 Jul 2025to 30 Dec 2027
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

  • Patients voluntarily join this study and sign the informed consent form (including consent for relevant tests on collected biological samples).
  • Male or female, aged ≥18 years and ≤75 years. Patients with pathologically or cytologically confirmed colorectal adenocarcinoma liver metastasis, and immunohistochemistry or genetic testing confirms pMMR/MSS.
  • Treatment-naive or relapsed colorectal cancer liver metastasis patients. For relapsed patients, the following must be met: no systemic antitumor therapy or radiotherapy within the past 1 year.
  • Primary tumor has been or can be radically resected.
  • Liver metastases are resectable and can achieve NED (no evidence of disease) status, meeting the following criteria:
  • Expected to achieve R0 resection through surgical resection and intraoperative ablation; Sufficient residual liver volume to preserve liver function; No distant metastases other than the liver. Planned for radical surgery after neoadjuvant therapy following MDT (multidisciplinary team) discussion.
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  • At least 1 measurable lesion defined by RECIST v1.1 criteria. ECOG performance status 0-1. Expected survival ≥12 months. No concomitant diseases that increase surgical risk to an unacceptable level.
  • Organ functions meet the following requirements (no use of any blood components, colony-stimulating factors, or other corrective treatment drugs within 14 days before enrollment):
  • Absolute neutrophil count ≥1.5×10⁹/L; Platelets ≥100×10⁹/L; Hemoglobin ≥90 g/L; Serum albumin ≥35 g/L; Thyroid-stimulating hormone (TSH) ≤1×ULN; Serum bilirubin ≤1.5×ULN; ALT and AST ≤3×ULN; International normalized ratio (INR) ≤1.5 or prothrombin time (PT) ≤1.5×ULN; Serum creatinine ≤1.5×ULN. Non-surgically sterilized patients or women of childbearing potential must use contraceptive measures (such as intrauterine devices, contraceptives, or condoms) during and for 3 months after the study treatment period. Non-surgically sterilized women of childbearing potential must have a negative serum or urine HCG test within 72 hours before study enrollment, and must not be lactating. Male patients with partners of childbearing potential must use effective contraception during the trial and for 3 months after the last dose.
  • In addition to routine outpatient and inpatient recruitment, patients will also be recruited through 易拉宝 (pop-up displays) and WeChat official account promotions.

Who cannot join

  • Presence of distant metastases other than the liver. Liver metastases have received prior antitumor therapy (chemotherapy, targeted therapy, immunotherapy, interventional therapy, etc.).
  • Liver metastases are unsuitable for surgical treatment. Residual toxicity from prior chemotherapy (excluding alopecia), such as grade ≥2 peripheral neuropathy.
  • Prior use of any therapy targeting T-cell costimulatory signaling pathways (e.g., anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4).
  • Active bleeding, ulcers, intestinal perforation, intestinal obstruction, or uncontrolled hypertension (uncontrollable by medication).
  • History of another primary malignancy within the past 3 years or concurrent malignancy (except cured basal cell carcinoma of the skin and cervical in situ carcinoma).
  • Active hepatitis B or hepatitis C infection. Active autoimmune disease or history of autoimmune disease (examples include but are not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism; vitiligo is permitted; asthma completely resolved in childhood without adult intervention is permitted; asthma requiring bronchodilator intervention is excluded).
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  • Current use of immunosuppressants or systemic corticosteroid therapy for immunosuppression (dose >10 mg/day prednisone or equivalent) within 2 weeks prior to enrollment.
  • Hypertension uncontrolled by antihypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg); uncontrolled cardiac symptoms or diseases, including:
  • NYHA class ≥2 heart failure;
  • unstable angina;
  • myocardial infarction within the past 1 year;
  • clinically significant supraventricular or ventricular arrhythmia requiring treatment/intervention;
  • QTc >450 ms (male) or QTc >470 ms (female). Coagulation abnormalities (INR >2.0, PT >16 seconds), bleeding diathesis, or current use of thrombolytic/anticoagulant therapy (prophylactic low-dose aspirin or low-molecular-weight heparin is permitted).
  • Arterial/venous thromboembolic events within 6 months prior to randomization (e.g., cerebrovascular accident [including transient ischemic attack, intracerebral hemorrhage, cerebral infarction], deep vein thrombosis, pulmonary embolism).
  • Known hereditary or acquired bleeding/thrombotic diathesis (e.g., hemophilia, coagulation disorders, thrombocytopenia).
  • Urinalysis showing proteinuria ≥ ++ confirmed by 24-hour urine protein >1.0 g. Active infection, unexplained fever ≥38.5°C within 7 days prior to first dose, or baseline white blood cell count >15×10⁹/L.
  • Congenital or acquired immunodeficiency (e.g., HIV infection). Systemic diseases such as cardiopulmonary insufficiency precluding tolerance of general anesthesia for partial nephrectomy or radical nephrectomy (note: likely a typo; original mentions "renal surgery," but context is colorectal cancer-should this be "hepatic surgery"?).
  • Other factors judged by the investigator to potentially affect study results or necessitate premature termination (e.g., alcohol/drug abuse, severe comorbidities requiring concurrent treatment [including mental illness], severe laboratory abnormalities, family/social factors impacting safety/compliance).

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Xuan Qijia xuan, Doctor contact

8618746023118

xuanqijia@126.com

About this study

Official title: A Prospective, Single-Arm, Multicenter Clinical Study on the Efficacy and Safety of Ivosimab Combined With Chemotherapy as Neoadjuvant Therapy in Patients With Resectable pMMR/MSS Colorectal Cancer Liver Metastases

The population receiving ivosimab combined with chemotherapy for neoadjuvant treatment of colorectal cancer liver metastasis.

Read the detailed description

The population receiving ivosimab combined with chemotherapy for neoadjuvant treatment of colorectal cancer liver metastasis

Being tested
Patients will receive ivosimab combined with the XELOX/FOLFOX regimen, followed by radical surgery 4-6 weeks after the last dose; adjuvant chemotherapy will continue for 3 months postoperatively.
Keywords
Immunotherapy

What participants receive

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

  • Patients will receive ivosimab combined with the XELOX/FOLFOX regimen, followed by radical surgery 4-6 weeks after the last dose; adjuvant chemotherapy will continue for 3 months postoperatively.Drug

    Patients will receive ivosimab combined with the XELOX/FOLFOX regimen, followed by radical surgery 4-6 weeks after the last dose; adjuvant chemotherapy will continue for 3 months postoperatively.

Study groups in NCT06972498
Study groupRoleWhat they receive
A Prospective, Single-Arm, Multicenter Clinical Study on the Efficacy and Safety of Ivosimab CombineExperimentalPatients will receive ivosimab combined with the XELOX/FOLFOX regimen, followed by radical surgery 4-6 weeks after the last dose; adjuvant chemotherapy will continue for 3 months postoperatively.
Receives: Drug: Patients will receive ivosimab combined with the XELOX/FOLFOX regimen, followed by radical surgery 4-6 weeks after the last dose; adjuvant chemotherapy will continue for 3 months postoperatively.

What is being measured

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

  1. ORR

    The objective response rate (ORR) in resectable pMMR/MSS colorectal cancer liver metastasis (CRLM) patients after neoadjuvant treatment with ivosimab combined with XELOX/FOLFOX.

    Measured: 4months

Timeline

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

  1. First posted15 May 2025
  2. Study start1 Jul 2025 (estimated)
  3. Primary completion30 Dec 2027 (estimated)
  4. Study completion30 Dec 2027 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06972498
Sponsor's protocol ID
KY-2025-099
Status last verified
May 2025
First submitted
4 May 2025
Last updated
15 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Patient Privacy and Confidentiality: Strict data protection regulations (e.g., GDPR, HIPAA) may prohibit sharing identifiable patient data, especially if anonymization is insufficient to mitigate risks.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Patients will receive ivosimab combined with the XELOX/FOLFOX regimen, followed by radical surgery 4-6 weeks after the last dose; adjuvant chemotherapy will continue for 3 months postoperatively. in people with Colorectal Cancer With Liver Metastasis, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine.

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 10 inclusion and 18 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 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.

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 Xuan Qijia xuan, Doctor (8618746023118, xuanqijia@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: 4months). 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 NCT06972498.

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 15 May 2025.

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