Ivonescimab Plus Chemotherapy in Patients With Initially Unresectable Colorectal Cancer Liver Metastases

NCT06848842 | Recruiting Phase 2

• 1 other identifier: NCC5043
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal Liver Metastases

Keywords

Colorectal Liver Metastases; initially unresectable; ivonescimab; objective response rate

Outcome Measures

Primary Outcomes (2)

• Objective Response Rate

  At the end of Cycle 8 (each cycle is 21 days)

• Treatment-Emergent Adverse Events

  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

  6 months

• Progression-free survival

  From date of enrollment until the date of first documented progression, assessed up to 2 years

• Overall Survival

  From date of enrollment until the date of death, assessed up to 2 years

• Recurrence-free survival

  From the date of curative resection until the date of first documented progression, assessed up to 2 years

• Disease control rate

  At the end of Cycle 8 (each cycle is 21 days)

Study Arms (1)

Experimental group

EXPERIMENTAL

Ivonescimab plus chemotherapy

Drug: Ivonescimab plus chemotherapy

Interventions

Ivonescimab plus chemotherapy DRUG

Ivonescimab, 20mg/kg, D1, Q3W; Oxaliplatin, 130mg/m2, D1, Q3W; Capecitabine, 1000mg/m2, BID, D1-D14, Q3W

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, China

RECRUITING

MeSH Terms

Interventions

Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Lin Yang

CONTACT

8613681015148; linyangcicams@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 27, 2025
• Study Start: September 18, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)