Alternating Systemic and Hepatic Artery Infusion Therapy As Adjuvant Treatment After Resection of Liver Metastases From Colorectal Cancer
- Conditions
- Resected Liver Metastases From Colorectal Cancer
- Interventions
- Registration Number
- NCT02529774
- Lead Sponsor
- Ye Xu
- Brief Summary
This adaptive seamless Phase II/III trial is to compare the efficacy and safety of adjuvant systemic chemotherapy (SCT) with or without hepatic arterial infusion (HAI) after complete hepatic resection for Chinese patients with metastatic colorectal cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 432
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Systemic Chemotherapy plus Hepatic Artery Infusion (HAI) Floxuridine (FUDR),Dexamethasone (DXM), Heparin in combination with Oxaliplatin and Capecitabine (CapeOX) or in combination with Oxaliplatin and Leucovorin and 5-FU (mFOLFOX6) - Systemic Chemotherapy Oxaliplatin and Capecitabine (CapeOX) or Oxaliplatin and Leucovorin and 5-FU (mFOLFOX6) -
- Primary Outcome Measures
Name Time Method Overall Survival 5-year Overall survival will be measured from the date of randomization up to the date of death of any cause
Liver Relapse-Free Survival Rate 3-year Liver Relapse-Free Survival (LRFS) is defined as the interval from the date of randomization to the date of liver localized metastatic relapse (with the exception of curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix) or death from any cause whichever occurs first.
- Secondary Outcome Measures
Name Time Method Disease free survival 3-year DFS is defined as the time interval from the date of randomization to the time of the first relapse at any site, death from any cause, or last recorded follow-up visit.
Trial Locations
- Locations (1)
Fudan University Shanghai Cancer Center China
🇨🇳Shanghai, Shanghai, China