This is a prospective, multi-center, randomized study evaluating the efficacy and safety of fruquintinib combined with chemotherapy vs bevacizumab combined with chemotherapy as second-line treatment in patients with metastatic colorectal cancer. Patients will receive fruquintinib+ FOLFIRI or bevacizumab+FOLFIRI as the second-line treatment. After receiving 4-6 months of second-line treatment, patients who achieve disease control will receive fruquintinib + capecitabine or bevacizumab+ capecitabine as maintenance treatment. All patients will be treated until progressive disease, death from any cause, unacceptable toxicity or informed consent withdrawal.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
116
Second-line treatment : Fruquintinib+FOLFIRI Drug: Fruquintinib 4mg, orally, once daily, 3 weeks on/ 1 week off, q4w Drug: FOLFIRI regimen Irinotecan 180 mg/m2, and LV 400 mg/m2 followed by bolus 5-fluorouracil 400mg/m2 and a 46-48-hour continuous infusion 2400mg/m2 5-fluorouracil on day 1, q2w Maintenance treatment:Fruquintinib+Capecitabine Drug: Fruquintinib 4mg, orally, once daily, 2 weeks on/ 1 week off, q3w Drug: Capecitabine 825 mg/m2, orally, twice daily, q3w
Second-line treatment : Bevacizumab+FOLFIRI Drug: Bevacizumab 5mg/kg on day 1, q2w Drug: FOLFIRI regimen Irinotecan 180 mg/m2, and LV 400 mg/m2 followed by bolus 5-fluorouracil 400mg/m2 and a 46-48-hour continuous infusion 2400mg/m2 5-fluorouracil on day 1, q2w Maintenance treatment:Bevacizumab+Capecitabine Drug: Bevacizumab 7.5mg/kg on day 1, q3w Drug: Capecitabine 825 mg/m2, orally, twice daily, q3w
The First Hospital of Putian City
Putian, Fujian, China
NOT_YET_RECRUITINGThe Fourth Hospital of Hebei Medical University and Hebei Tumor Hospital
Shijiazhuang, Hebei, China
NOT_YET_RECRUITINGHenan Cancer Hospital
Zhengzhou, Henan, China
NOT_YET_RECRUITINGXiangya Hospital of Central South University
Changsha, Hunan, China
NOT_YET_RECRUITINGQilu Hospital of Shandong University (QLH)
Jinan, Shandong, China
NOT_YET_RECRUITINGThe Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
NOT_YET_RECRUITINGRenji hospital, Shanghai Jiaotong University
Shanghai, Shanghai Municipality, China
NOT_YET_RECRUITINGChanghai Hospital
Shanghai, Shanghai Municipality, China
NOT_YET_RECRUITINGRuijin Hospital Affiliated to The Shanghai Jiao Tong University Medical School
Shanghai, Shanghai Municipality, China
NOT_YET_RECRUITINGthe Second Affiliated Hospital of Medical College of Zhejiang University
Hangzhou, Zhejiang, China
NOT_YET_RECRUITING...and 3 more locations
Progression-Free Survival (PFS)
time from randomization to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator
Time frame: from randomization up to progressive disease or EOT due to any cause, assessed up to 1 year
Objective response rate (ORR)
the proportion of patients with complete response or partial response, using RECIST v 1.1.
Time frame: from randomization up to progressive disease or EOT due to any cause, assessed up to 1 year
Disease Control Rate (DCR)
the proportion of patients with complete response, partial response or stable disease, using RECIST v 1.1.
Time frame: from randomization up to progressive disease or EOT due to any cause, assessed up to 1 year
Overall survival (OS)
time from randomization to death from any cause.
Time frame: from randomization until death due to any cause, assessed up to 2 year
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