Ivonescimab Plus Chemotherapy in Patients With Initially Unresectable Colorectal Cancer Liver Met… (NCT06848842) | Clinical Trial Compass
RecruitingPhase 2
Ivonescimab Plus Chemotherapy in Patients With Initially Unresectable Colorectal Cancer Liver Metastases
China40 participantsStarted 2025-09-18
Plain-language 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. 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓. 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.
✓. Eastern Cooperative Oncology Group performance status 0-1
✓. Life expectancy ≥12 weeks.
Exclusion criteria
✕. Definite extrahepatic metastases.
✕
What they're measuring
1
Objective Response Rate
Timeframe: At the end of Cycle 8 (each cycle is 21 days)
2
Treatment-Emergent Adverse Events
Timeframe: From the date of enrollment until 90 days after the Cycle 8 (each cycle is 21 days)
Trial details
NCT IDNCT06848842
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences
✕. 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.
✕. Hypertension with systolic blood pressure ≥160mmHg or diastolic blood pressure ≥100mmHg despite antihypertensive treatment.
✕. Major cardiovascular events within 12 months prior to enrollment.