This is a prospective, open-labelled study to evaluate the efficacy and safety of sequetial transarterial chemoembolization with lipiodol and neoadjuvant chemotherapy in the treatment of initial unresectable colorectal cancer. The progression-free-survival (PFS) will be evaluated as the primary endpoints.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Transarterial infusion chemotherapy: Oxaliplatin(85mg/m\^2)+Raltitrexed(3mg) Chemoembolization: Lipiodol emulsion (lipiodol 10ml+ Oxaliplatin 85mg +Lidocaine 1ml),The endpoint for embolization was defined as stagnation of blood flow of the posterior mesenteric artery. Intervention cycle:4W; Treatment times: 2. followed by mFOLFOX6
mFOLFOX6, Q2W
PFS
PFS was defined as the time from recruitment to the first documented progressive disease (PD) or death due to any cause, whichever occurred first.
Time frame: up to 3 years
ORR
ORR is defined as the percentages of patients, relative to the total of enrolled subjects, achieving a complete (CR) or partial (PR) response, according to RECIST 1.1 criteria
Time frame: up to 3 years
Overall survival (OS)
The time from recruitment to death due to any cause.
Time frame: up to 3 years
Pathological response rate (PCR+MPR)
Pathologic complete response (pCR) was defined as absence of viable tumor in the post-treatment surgical specimens and major pathologic response (MPR) was defined as ≤ 10% viable tumor.
Time frame: up to 3 years
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