Study of Cetuximab in Combination With Chemotherapy for the First Treatment of Metastatic Colorectal Cancer
Patients will be eligible for inclusion if their primary tumors have been resected and if
the patients have histologically confirmed wild-type-KRAS colorectal adenocarcinoma with
synchronous liver-confined metastases deemed non-resectable. Eligible patients will be
randomly assigned to chemotherapy plus cetuximab (arm A) or chemotherapy alone (arm B).
Treatment will be planned to commence between 2 and 4 weeks after the primary surgery.
Treatment will continue until tumor response indicates suitability for surgery for liver
metastases or until disease progression or unacceptable toxic effects. The primary endpoint
is the conversion rate to radical resection for liver metastases，which will be assessed by
local multidisciplinary team (includes more than three liver surgeons and one radiologist)
with the use of contrast-enhanced CT or MRI after 4 cycles and then every other 2 cycles up
to 12 cycles. To provide an objective assessment of changes in resectability, radiological
images will be presented by a radiologist to more than 3 liver surgeons, who are blinded to
the clinical data. Patients will be considered resectable if 50% or more of surgeons vote
for radical resection of LM. For patients whose liver-metastases are assessed resectable,
resection should be scheduled to be performed within 2~3 weeks of the last treatment cycle.
Following resection, patients will be advised to continue the same therapeutic regimen until
the treatments reach a sum of 12 cycles.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
the rate of patients converted to resection for liver metastases
To explore whether cetuximab in combination with chemotherapy as treatment could improve the resection rate in patients with KRAS wild-type, unresectable colorectal liver-limited metastases compared with chemotherapy alone.
China: Food and Drug Administration