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

ConditionColorectal Liver Metastases
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Single group

Treatments tested in this trial

  • Ivonescimab plus chemotherapy

    Drug

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

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Experimental groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective Response Rate

Time frame
At the end of Cycle 8 (each cycle is 21 days)
2

Treatment-Emergent Adverse Events

Time frame
From the date of enrollment until 90 days after the Cycle 8 (each cycle is 21 days)

Secondary outcomes

1

No evidence of disease rate

Time frame
6 months
2

Progression-free survival

Time frame
From date of enrollment until the date of first documented progression, assessed up to 2 years
3

Overall Survival

Time frame
From date of enrollment until the date of death, assessed up to 2 years
4

Recurrence-free survival

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Lead sponsor

Source ClinicalTrials.gov
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