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Regorafenib Combined With Irinotecan Drug-Eluting Beads for Colorectal Cancer Liver Metastases

ConditionsColorectal Cancer Liver MetastasesRegorafenib
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSun Yat-sen University

About this trial

This study is a multicentre, prospective, randomised trial, aims to evaluate the efficacy and safety of Irinotecan Drug-Eluting Beads combined with regorafenib as the third-line treatment for a patient with colorectal cancer liver metastases. The study is planned to enrolled 126 patients failing first- and second-line standard chemotherapy treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients over 18 years of age, of any race or sex, who have histologic or radiologic proof of colorectal cancer to the liver, who are able to give informed consent, will be eligible.

Patients failing first- and second-line standard systemic chemotherapy.

Patients with at least one measurable liver metastases, with size > 1cm response evaluation criteria in solid tumors (RECIST)

Patients with liver dominant disease defined as ≥80% tumor body burden confined to the liver

Disqualifiers

Prior treatment with TACE, regorafenib or fruquintinib

Patients with brain metastases

With serious heart, kidney, bone marrow, or lung, central nervous system diseases.

Patients suffered with other cancer.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Regorafenib and DIBIRI

    Drug

    Drug: Regorafenib Regorafenib will be given 3 weeks on/1 week off (initial dose: 80 mg od po.) Drug: Irinotecan it will be mixed in eluting-beads and injected in the tumor. Procedure: TACE Transcatheter arterial chemoembolization（TACE）is a minimally invasive procedure performed to decrease the tumor's blood supply. Device: drug eluting-bead The eluting-bead,loaded with irinotecan (DEBIRI) to treat patients with hepatic metastases from colorectal cancer.

  • Regorafenib

    Drug

    Drug: Regorafenib Regorafenib will be given 3 weeks on/1 week off (initial dose: 80 mg od po.)

Treatment groups

126 Participants
are divided into 2 treatment groups
Group A: Irinotecan Drug-Eluting Beads combined with regorafenibExperimental treatment 1 intervention
Group B: regorafenibActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Overall Survival (OS)

OS is defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.

Time frame
24 months

Secondary outcomes

1

Progression-Free Survival (PFS)

The PFS is defined as the time from the start of treatment to the date of first documented PD or death as a result of any cause, whichever occurred first. When a patient was alive and without progression, PFS was censored at the date of the last disease assessment.

Time frame
24 months
2

Objective Response Rate (ORR)

The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR)

Time frame
24 months
3

Disease Control Rate (DCR)

DCR is defined as the percentage of subjects whose best response was not Progressive Disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR) + total number of Partial Response (PR) + total number of Stable Disease (SD); CR, PR, or SD had to be maintained for at least 28 days from the first demonstration of that rating)

Time frame
24 months
4

Duration of response (DOR)

It was defined as the time from the first judgment of complete remission (CR) or partial remission (PR) to the discovery of disease progression (PD) after treatment

Time frame
24 months

Other outcomes

Sponsors and contacts

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

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov
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