Liver Metastasis Colon Cancer
Conditions
Keywords
FOLFOXIRI, cetuximab, bevacizumab
Brief summary
To compare the efficacy of FOLFOXIRI plus Cetuximab and FOLFOXIRI plus Bevacuzumab in the conversion therapy of right-sided colon cancer liver metastases
Interventions
DRUGCetuximab
one group plus cetuximab
DRUGBevacizumab
one group plus bevacizumab
DRUGFOLFOXIRI
FOLFOXIRI
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* ECOG perfomance 0-1 * pathologically confirmed colorectal carcinoma, with RAS wild type * inital unresectable liver metastases discussed by MDT * prior no systemical therapy or exceed 6 months after the adjuvant chemotherapy of primary tumor surgery. * without extraheptic metastatic lesions, except for locally controlled lung metastases (RFA or SBRT) * adequate blood, liver and renal function * expected survival longer than 6 months
Exclusion criteria
* with bleeding risk * interestinal obstruction or disease * uncontrolled hypertension and severe heart disease * previous severe thrombotic events * central nervous system metastases * accompanied with other malignant tumor
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR | up to 8 weeks | objective response rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| R0 resection rate of liver metastases | up to 8 weeks | R0 resection rate of liver metastases |
| NED rate | up to 8 weeks | percentage of patients who reach NED |
| OS | up to 6 months | overal survival |
| PFS | up to 8 weeks | progression free survival |
Countries
China
Contacts
Primary ContactWenhua Li
Outcome results
None listed