The study aims to evaluate the efficacy and safety of fruquintinib combined with mFOLFOX6 + synchronous radiotherapy as neoadjuvant therapy in middle and low locally advanced rectal cancer patients with no previous anti-tumor treatment.
The study aims to evaluate the efficacy and safety of fruquintinib combined with mFOLFOX6 + synchronous radiotherapy as neoadjuvant therapy in middle and low locally advanced rectal cancer patients with no previous anti-tumor treatment. Approximately 40 patients will be enrolled and undergo combination neoadjuvant therapy, followed by TME and mFOLFOX6 adjuvant therapy, peri-operative treatment will last for 6 months. The primary endpoint is pCR.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
mFOLFOX6: The mFOLFOX6 regimen will be administered on Day 1 of each treatment cycle. This regimen consists of oxaliplatin 85 mg/m2 IV given over 2 hours, leucovorin 400 mg/m2 IV given over 2 hours, and fluorouracil 400 mg/m2 IV bolus, followed by fluorouracil 1200 mg/m2 per day for 2 days, continuous infusion. fruquintinib: 3mg/d, qd po, for 7 weeks continuously. Radiation Therapy: radiation 45.0\~50.0 Gy (1.8-2.0 Gy/day or 25 fractions weeks 3-7)
pCR
pathological complete response rate assessed by the investigator
Time frame: about 2 months
MPR
major pathological response rate assessed by the investigator
Time frame: about 2 months
ORR
objective response rate assessed by the investigator
Time frame: about 2 months
R0 resection rate
R0 resection rate
Time frame: about 2 months
DFS
DFS (Disease-free survival) will be calculated from the date of first administration of study drug to the date of recurrence or death by any reason.
Time frame: about 3 years
OS
OS will be calculated from the date of first administration of study drug to the date of death by any reason.
Time frame: about 5 years
TRAEs
treatment-related adverse events by CTCAE v5.0
Time frame: about 6 months
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