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Status unknownNCT04003792Updated Oct 20, 2020

Treatment With Hepatic Arterial Infusion of Oxaliplatin in Combination With Systemic FOLFIRI Chemotherapy and Bevacuzimab in Patients With Liver-only Colorectal Liver Metastases (CRLM): Conversion to Complete Resection in Patients With Initially Inoperable Liver-only CRLM.

A Phase 2 interventional study of oxaliplatin and FOLFIRI Protocol in Liver Metastasis Colon Cancer, sponsored by Rabin Medical Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-20.

Sponsored by Rabin Medical Center · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
49
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

A few studies have documented that some patients can be down-staged from an initially inoperable state to a potentially resectable state. Five-year survival in initially inoperable patients that ultimately come to a complete resection appears to be similar to patients who are resected at first presentation. The investigators goal is to assess the rate of conversion to complete resection in patients with initially inoperable liver-only metastases due to colorectal cancer after treatment with HAI of oxaliplatin with FOLFIRI and bevacuzimab systemic treatment.

02

Conditions studied

  • Liver Metastasis Colon Cancer
03

In context

Neoplasm Metastasis

3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.

This study's planned enrollment of 49 is close to the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.

Browse Neoplasm Metastasis studies →

Lead sponsor

Rabin Medical Center is the lead sponsor of 385 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Subject Inclusion Criteria:

  • Histologically confirmed colorectal adenocarcinoma metastatic to the liver.
  • The patient must have inoperable liver metastases as agreed upon by any two hepatobiliary surgeons and the assigned radiologist.
  • A patient may have had prior chemotherapy or be previously untreated.
  • ECOG PS \<2

Subject Exclusion Criteria:

  • Prior radiation, hepatic thermo ablation or resection (other than biopsy) to the liver.
  • Patient may not have received prior treatment with hepatic artery infusion (HAI).
  • Extrahepatic metastases
  • Female patients who are pregnant or lactating
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
49 participants (estimated)

Study arms

  • Experimental
    single arm prospective trial

    Drug: oxaliplatin · Drug: FOLFIRI Protocol · Drug: Bevacizumab

Interventions

  • Drugoxaliplatin

    intra-arterial oxaliplatin administration

  • DrugFOLFIRI Protocol

    systemic FOLFIRI chemotherapy

  • DrugBevacizumab

    systemic bevacuzimab therapy

06

What researchers measure

Primary outcomes

  1. conversion rate to complete resection in patients with initially inoperable liver-only metastases due to colorectal cancer after treatment with HAI of oxaliplatin with FOLFIRI and bevacuzimab systemic treatment.

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 20, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04003792
Lead sponsor
Rabin Medical Center
Responsible party
Eran Sadot (Head of Hepatopancreatobiliary service, Principal Investigator, Rabin Medical Center) — Principal investigator
First posted
Jul 1, 2019
Start date
Jan 1, 2020
Primary completion
Jan 2022 (estimated)
Completion
Jan 2022 (estimated)
Last update
Oct 20, 2020

Study contacts

Eran Sadot, MD
Contact
eransadot@gmail.com
+972-3-9376201

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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