Phase II clinical trial on systemic oxaliplatin chemotherapy plus molecular target therapy combined with hepatic arterial infusion (HAI) therapy for colorectal liver metastases
Phase 2
- Conditions
- Colorectal cancer
- Registration Number
- JPRN-UMIN000019466
- Lead Sponsor
- Department of Gastroenterological Surgery, Tokai University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 47
Inclusion Criteria
Not provided
Exclusion Criteria
1. Intestinal pneumonia presenting clinical signs. 2. Severe infectious diseases. 3. Severely complicated diseases including heart failure, liver malfunction, renal failure and uncontrolled diabetes. 4. Anorexia 5. Women who are pregnant, lactate or have a probability of pregnancy. 6. History of allergy against fluorouracil, leucovorin, oxaliplatin and/or cetuximab. 7. Patients whom the researcher judged as ineligible.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Two-year relative-free survival after liver surgery Overall survival
- Secondary Outcome Measures
Name Time Method Adverse events Response rate Progression-free survival in unresectable cases Intra- and extra-hepatic recurrence rate