This is an open label, randomized, phase Ⅲ study to treat subjects with RAS/BRAF wild-type, unresectable metastatic colorectal cancer. The patients will be randomized into two arms consist of Anlotinib (3 weeks/cycle) + CapeOx and Bevacizumab (3 week/cycle) + CapeOx at a ratio of 1:1. This study is conducted to assess the efficacy and safety of Anlotinib and Chemotherapy as first-line treatment in subjects with RAS/BRAF wild-type Metastatic Colorectal Cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
748
Anlotinib hydrochloride capsule 12mg given orally in fasting conditions, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21);
Bevacizumab 7.5mg/kg, intravenous drip, on Day 1
Oxaliplatin 130mg/m2, intravenous drip, on Day 1;
Capecitabine 850mg/m2 administrated orally twice daily from Day 1-14.
The People's Hospital of Chizhou
Chizhou, Anhui, China
Fujian Medical University Union Hospital
Fuzhou, Anhui, China
Anhui Provincial Hospital
Hefei, Anhui, China
Anhui Cancer Hospital
Hefei, Anhui, China
Xuancheng People's Hospital
Xuancheng, Anhui, China
China-Japan Friendship Hospital
Progression Free Survival (PFS) assessed by IRC
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
Time frame: Baseline up to 15 months
Progression free survival (PFS)
PFS defined as the time from first dose until the first documented progressive disease (PD) or death from any cause.
Time frame: Baseline up to 15 months
Overall survival (OS)
OS defined as the time from the first dose to death from any cause. Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up.
Time frame: Baseline up to 20 months
Objective Response Rate(ORR)
Percentage of subjects achieving complete response (CR) and partial response (PR) .
Time frame: Baseline up to 15 months
Disease Control Rate (DCR)
Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).
Time frame: Baseline up to 15 months
Duration of Response (DOR)
DOR was defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of disease progression or to death due to any cause, whichever occurred first.
Time frame: Baseline up to 15 months
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Beijing, Beijing Municipality, China
Peking University Frist Hospital
Beijing, Beijing Municipality, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Fuling Hospital Affiliated to Chongqing University
Chongqing, Chongqing Municipality, China
...and 82 more locations