Colorectal Liver MetastasesPhase 2NCT06848842
Ivonescimab Plus Chemotherapy in Patients With Initially Unresectable Colorectal Cancer Liver Metastases
A Phase 2 study testing Ivonescimab plus chemotherapy in people with Colorectal Liver Metastases, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if ivonescimab plus chemotherapy works to treat colorectal cancer liver metastases that cannot be completely removed. It will also learn about the safety of ivonescimab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Liver Metastases
- What is being tested?
- Ivonescimab plus chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 18 Sep 2025to Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Histologically confirmed colorectal adenocarcinoma.
- Radiologically confirmed liver-only metastases. Patients with ≤1 cm extrahepatic lesions not confirmed as metastatic are eligible.
- No prior systemic therapy or local therapy for metastatic lesions, or completion of neoadjuvant/adjuvant chemotherapy ≥6 months before diagnosed disease recurrence.
- Liver metastases considered unresectable or borderline resectable by multidisciplinary evaluation.
- Liver metastases were measurable according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
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- Eastern Cooperative Oncology Group performance status 0-1
- Life expectancy ≥12 weeks.
- No contraindications to hepatic resection/ablation, and primary tumor resectable or previously resected.
- Adequate organ function as determined by normal bone marrow function (hemoglobin ≥80 g/L, absolute neutrophil count ≥1.5×10⁹/L, and platelets ≥100×10⁹/L), renal function (serum creatinine ≤1.5×upper limit of normal [ULN] and creatinine clearance ≥30 mL/min), liver function (serum bilirubin ≤2×ULN and serum transaminases ≤5×ULN).
Who cannot join
- Definite extrahepatic metastases.
- dMMR or MSI-H colorectal cancer.
- Intolerance to the study drug during prior neoadjuvant/adjuvant therapy.
- Toxicities from prior therapy have not resolved to ≤ Grade 1 (according to NCI-CTCAE v5.0), except for alopecia (any grade) and peripheral neuropathy (≤ Grade 2).
- History of or concurrent other malignancies within the past 5 years, except cured localized tumors.
- Surgery performed within 28 days prior to enrollment.
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- Hypertension with systolic blood pressure ≥160mmHg or diastolic blood pressure ≥100mmHg despite antihypertensive treatment.
- Major cardiovascular events within 12 months prior to enrollment.
- History of severe bleeding tendency or coagulation disorders; tumor encasement of major blood vessels or significant necrosis or cavitation, and the investigator deems participation in the study may pose a bleeding risk.
- Active autoimmune disease requiring systemic treatment within the past 2 years.
- History of immunodeficiency, positive HIV antibody test, or long-term use of corticosteroids or other immunosuppressants.
- Prior history of allogeneic bone marrow or organ transplantation.
- Received live vaccines within 30 days prior to the first dose or plans to receive live vaccines during the study period.
- Allergy to any component of the study drugs; history of severe hypersensitivity reactions to other monoclonal antibodies.
- Women who are pregnant or breastfeeding.
- Severe comorbidities or any other condition that precludes safe administration of the study treatment, including but not limited to symptomatic congestive heart failure (Class II or higher per NYHA classification), unstable angina, acute myocardial ischemia, poorly controlled arrhythmias, decompensated cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, severe active peptic ulcer disease or gastritis, or psychiatric/social conditions that may limit compliance with study requirements or impair the subject's ability to provide written informed consent.
- Any other condition deemed by the investigator as unsuitable for participation in this study.
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, 1 recruiting
- Recruiting
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing
Lin Yang, 8613681015148, linyangcicams@126.com
About this study
Official title: A Phase II Clinical Study of Ivonescimab Plus CAPOX Regimen in Patients With Initially Unresectable Colorectal Cancer Liver-only Metastases
The goal of this clinical trial is to learn if ivonescimab plus chemotherapy works to treat colorectal cancer liver metastases that cannot be completely removed. It will also learn about the safety of ivonescimab. The main questions it aims to answer are:
Does ivonescimab plus chemotherapy raise the objective response rate? What medical problems do participants have when receiving ivonescimab plus chemotherapy?
Participants will:
Receive ivonescimab and chemotherapy every 3 weeks, no more than 8 cycles. Visit the clinic once every 2 cycles (6 weeks) for checkups and tests. Receive curative surgery, maintenance therapy, or discontinue study treatment according to the expert team's evaluation.
- Conditions
- Colorectal Liver Metastases
- Being tested
- Ivonescimab plus chemotherapy
- Keywords
- Colorectal Liver Metastases, initially unresectable, ivonescimab, objective response rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ivonescimab plus chemotherapyDrug
Ivonescimab, 20mg/kg, D1, Q3W; Oxaliplatin, 130mg/m2, D1, Q3W; Capecitabine, 1000mg/m2, BID, D1-D14, Q3W
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Ivonescimab plus chemotherapy Receives: Drug: Ivonescimab plus chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Measured: At the end of Cycle 8 (each cycle is 21 days)
Treatment-Emergent Adverse Events
Measured: From the date of enrollment until 90 days after the Cycle 8 (each cycle is 21 days)
Secondary outcomes (7)
No evidence of disease rate
Measured: 6 months
Progression-free survival
Measured: From date of enrollment until the date of first documented progression, assessed up to 2 years
Overall Survival
Measured: From date of enrollment until the date of death, assessed up to 2 years
Recurrence-free survival
Measured: From the date of curative resection until the date of first documented progression, assessed up to 2 years
Disease control rate
Measured: At the end of Cycle 8 (each cycle is 21 days)
Treatment-related adverse events
Measured: From the date of enrollment until 90 days after the Cycle 8 (each cycle is 21 days)
Immunotherapy-related adverse events
Measured: From the date of enrollment until 180 days after the Cycle 8 (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start18 Sep 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Liver MetastasesStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LIN YANG, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06848842
- Sponsor's protocol ID
- NCC5043
- Status last verified
- Sep 2025
- First submitted
- 6 Feb 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study of Ivonescimab Plus CAPOX Regimen in Patients With Initially Unresectable Colorectal Cancer Liver-only Metastases
- ClinicalTrials.gov ID
- NCT06848842
- Acronym / sponsor ID
- NCC5043
- Conditions
- Colorectal Liver Metastases
- Keywords
- Colorectal Liver Metastases, initially unresectable, ivonescimab, objective response rate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 18 Sep 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 27 Feb 2025 (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.
The goal of this clinical trial is to learn if ivonescimab plus chemotherapy works to treat colorectal cancer liver metastases that cannot be completely removed. It will also learn about the safety of ivonescimab. The main questions it aims to answer are:
Does ivonescimab plus chemotherapy raise the objective response rate? What medical problems do participants have when receiving ivonescimab plus chemotherapy?
Participants will:
Receive ivonescimab and chemotherapy every 3 weeks, no more than 8 cycles. Visit the clinic once every 2 cycles (6 weeks) for checkups and tests. Receive curative surgery, maintenance therapy, or discontinue study treatment according to the expert team's evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Ivonescimab plus chemotherapyIvonescimab plus chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥18 years.
- Histologically confirmed colorectal adenocarcinoma.
- Radiologically confirmed liver-only metastases. Patients with ≤1 cm extrahepatic lesions not confirmed as metastatic are eligible.
- No prior systemic therapy or local therapy for metastatic lesions, or completion of neoadjuvant/adjuvant chemotherapy ≥6 months before diagnosed disease recurrence.
- Liver metastases considered unresectable or borderline resectable by multidisciplinary evaluation.
Key exclusion criteria (17 listed)
- Definite extrahepatic metastases.
- dMMR or MSI-H colorectal cancer.
- Intolerance to the study drug during prior neoadjuvant/adjuvant therapy.
- Toxicities from prior therapy have not resolved to ≤ Grade 1 (according to NCI-CTCAE v5.0), except for alopecia (any grade) and peripheral neuropathy (≤ Grade 2).
- History of or concurrent other malignancies within the past 5 years, except cured localized tumors.
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 |
|---|---|---|
| Ivonescimab plus chemotherapyIvonescimab, 20mg/kg, D1, Q3W; Oxaliplatin, 130mg/m2, D1, Q3W; Capecitabine, 1000mg/m2, BID, D1-D14, Q3W | Drug | Experimental group |
Primary outcome
Objective Response Rate
Time frame: At the end of Cycle 8 (each cycle is 21 days)
Treatment-Emergent Adverse Events
Time frame: From the date of enrollment until 90 days after the Cycle 8 (each cycle is 21 days)
7 secondary outcomes
No evidence of disease rate
Time frame: 6 months
Progression-free survival
Time frame: From date of enrollment until the date of first documented progression, assessed up to 2 years
Overall Survival
Time frame: From date of enrollment until the date of death, assessed up to 2 years
Recurrence-free survival
Time frame: From the date of curative resection until the date of first documented progression, assessed up to 2 years
Disease control rate
Time frame: At the end of Cycle 8 (each cycle is 21 days)
Treatment-related adverse events
Time frame: From the date of enrollment until 90 days after the Cycle 8 (each cycle is 21 days)
Immunotherapy-related adverse events
Time frame: From the date of enrollment until 180 days after the Cycle 8 (each cycle is 21 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 Oct 2025.
- Individual participant dataSharing planned: No
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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 Ivonescimab plus chemotherapy in people with Colorectal Liver Metastases, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 10 inclusion and 17 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 1 Oct 2025. 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 Lin Yang (8613681015148, linyangcicams@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: At the end of Cycle 8 (each cycle is 21 days)). The study lists 2 primary outcomes in all. 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 Oct 2025.