Actively Recruiting
Ivonescimab Plus Chemotherapy in Patients With Initially Unresectable Colorectal Cancer Liver Metastases
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2025-10-01
40
Participants Needed
1
Research Sites
88 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 single 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 disease recurrence
- Liver metastases considered unresectable or borderline resectable by multidisciplinary evaluation
- Liver metastases measurable by RECIST version 1.1
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Life expectancy of at least 12 weeks
- No contraindications to hepatic resection or ablation, with primary tumor resectable or previously resected
- Adequate organ function including bone marrow, kidney, and liver function as defined by specific laboratory thresholds
You will not qualify if you...
- Definite extrahepatic metastases
- dMMR or MSI-H colorectal cancer
- Intolerance to study drug during prior neoadjuvant/adjuvant therapy
- Toxicities from prior therapy not resolved to Grade 1 or less, except alopecia and peripheral neuropathy (Grade 2 or less)
- History or current other malignancies within past 5 years, except cured localized tumors
- Surgery performed within 28 days before enrollment
- Hypertension uncontrolled despite treatment (systolic ≥160 mmHg or diastolic ≥100 mmHg)
- Major cardiovascular events within 12 months before enrollment
- History of severe bleeding or coagulation disorders or 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 use of immunosuppressants
- Prior allogeneic bone marrow or organ transplantation
- Received live vaccines within 30 days before first dose or plans to receive during study
- Allergy to study drugs or severe hypersensitivity to other monoclonal antibodies
- Pregnant or breastfeeding women
- Severe comorbidities or conditions that prevent safe treatment including specific heart, liver, kidney, metabolic, gastrointestinal, or psychiatric conditions
- 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
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here