Actively Recruiting
A Phase II Clinical Study of Ivonescimab Plus CAPOX Regimen in Patients With Initially Unresectable Colorectal Cancer Liver-only Metastases
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2025-10-01
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating ivonescimab combined with chemotherapy to treat patients with colorectal cancer that has spread to the liver and cannot be fully removed by surgery. This Phase II clinical trial aims to see if this combination increases the rate of tumor response and to understand the safety and medical issues participants might experience. The study focuses on patients with liver-only metastases that are initially unresectable or borderline resectable. Participants will receive ivonescimab at 20 mg/kg on day 1 every 3 weeks along with chemotherapy drugs oxaliplatin and capecitabine following a specific dosing schedule. Treatment is given in cycles of 21 days, up to a maximum of 8 cycles. During the study, participants will visit the clinic every 6 weeks for checkups and tests, and after treatment cycles, they may have surgery, maintenance therapy, or stop study treatment based on expert evaluation. Throughout the trial, participants will undergo regular assessments to monitor tumor response using standardized criteria, document any side effects or adverse events, and evaluate survival outcomes up to two years. Safety monitoring extends up to 180 days after treatment cycles. The total duration of participation depends on treatment response, surgery, and follow-up assessments to gather comprehensive data on the therapy's impact.
CONDITIONS
Brief Title
Ivonescimab Plus Chemotherapy in Patients With Initially Unresectable Colorectal Cancer Liver Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed colorectal adenocarcinoma
- Radiologically confirmed liver-only metastases; patients with up to 1 cm extrahepatic lesions not confirmed as metastatic are eligible
- No prior systemic or local therapy for metastatic lesions, or completed neoadjuvant/adjuvant chemotherapy at least 6 months before recurrence diagnosis
- Liver metastases considered unresectable or borderline resectable by multidisciplinary evaluation
- Measurable liver metastases according to RECIST version 1.1 criteria
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Life expectancy at least 12 weeks
- No contraindications to hepatic resection or ablation; primary tumor resectable or previously resected
- Adequate organ function including normal bone marrow, renal, and liver function based on specified laboratory values
You will not qualify if you...
- Definite extrahepatic metastases
- dMMR or MSI-H colorectal cancer
- Intolerance to the study drug during prior neoadjuvant or adjuvant therapy
- Toxicities from prior therapy not resolved to Grade 1 or better, except alopecia and mild peripheral neuropathy
- History of or current other malignancies within past 5 years, except cured localized tumors
- Surgery within 28 days prior to enrollment
- Hypertension uncontrolled despite treatment with systolic blood pressure ≥160mmHg or diastolic ≥100mmHg
- Major cardiovascular events within 12 months before enrollment
- History of severe bleeding or coagulation disorders, tumor involving major blood vessels posing bleeding risk
- Active autoimmune disease requiring systemic treatment within past 2 years
- History of immunodeficiency, positive HIV test, or long-term immunosuppressant use
- Prior allogeneic bone marrow or organ transplantation
- Live vaccines within 30 days before first dose or planned during study
- Allergy to study drug components or severe hypersensitivity to monoclonal antibodies
- Women who are pregnant or breastfeeding
- Severe comorbidities or conditions precluding safe study treatment administration
- Any other condition deemed unsuitable by the investigator for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 8 cycles of 21 days each
Participants receive Ivonescimab plus chemotherapy to treat unresectable colorectal cancer liver metastases.
8 treatment cycles, each lasting 21 days
Duration - Up to 6 months after treatment ends
Participants are monitored for treatment-emergent and immunotherapy-related adverse events and survival outcomes after treatment completion.
Visits up to 6 months after last treatment cycle
Trial Site Locations
Total: 1 location
1
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China
Actively Recruiting
Research Team
L
Lin Yang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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