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.

Program Status

Recruiting

Phase

Phase 2

Prior Immunotherapy Allowed

Yes

CRC-directed Trial

Yes

Drugs

Bevacizumab, FOLFIRI Protocol, oxaliplatin

Tags

MSI-H/ MMRd, MSS/ MMRp

Comments

For patients with only liver metastases from CRC, that are not resectable but have the potential to convert to resectable: innovative *procedure* (HAI with oxaliplatin) with standard of care agents.
HAI (hepatic arterial infusion) of oxaliplatin (the agent is delivered *directly* to the liver) with intravenous, standard of care FOLFIRI and bevacuzimab (systemic treatment).
Patient may have had prior chemotherapy or be previously untreated.
Metastases outside liver not allowed.
No prior local treatment to the liver allowed (no prior HAI, radiation, surgery, etc. to the liver allowed)

Location Location Status
Israel
Rabin Medical Center
Petach Tikva
Recruiting

Contacts

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

Inclusion Criteria

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

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

NCT ID

NCT04003792

Date Trial Added

2019-07-01

Updated Date

2020-10-20