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出境医 / 临床实验 / 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

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

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Liver Metastasis Colon Cancer Drug: oxaliplatin Drug: FOLFIRI Protocol Drug: Bevacizumab Phase 2

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 49 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: single arm prospective trial Drug: oxaliplatin
intra-arterial oxaliplatin administration

Drug: FOLFIRI Protocol
systemic FOLFIRI chemotherapy

Drug: Bevacizumab
systemic bevacuzimab therapy
Outcome Measures
Primary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

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

Locations
Layout table for location information
Israel
Rabin Medical Center Recruiting
Petach Tikva, Israel
Contact: Eran Sadot       eransadot@gmail.com   
Sponsors and Collaborators
Rabin Medical Center
Tracking Information
First Submitted Date  ICMJE June 27, 2019
First Posted Date  ICMJE July 1, 2019
Last Update Posted Date October 20, 2020
Actual Study Start Date  ICMJE January 1, 2020
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2019) 		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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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.
Official Title  ICMJE 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.
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Liver Metastasis Colon Cancer
Intervention  ICMJE
  • Drug: oxaliplatin
    intra-arterial oxaliplatin administration
  • Drug: FOLFIRI Protocol
    systemic FOLFIRI chemotherapy
  • Drug: Bevacizumab
    systemic bevacuzimab therapy
Study Arms  ICMJE Experimental: single arm prospective trial
Interventions:
  • Drug: oxaliplatin
  • Drug: FOLFIRI Protocol
  • Drug: Bevacizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 28, 2019) 		49
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2022
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Eran Sadot, MD +972-3-9376201 eransadot@gmail.com
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04003792
Other Study ID Numbers  ICMJE 0275-19-RMC
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Eran Sadot, Rabin Medical Center
Study Sponsor  ICMJE Rabin Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Rabin Medical Center
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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