This phase I/II study was designed to evaluate the efficacy and safety of fruquintinib combination with capecitabine in maintenance treatment after first-line chemotherapy combined with cetuximab.
At present, most studies use chemotherapy combined with cetuximab or cetuximab alone as the maintenance treatment scheme after the first-line regimen containing cetuximab. However, the skin reaction caused by cetuximab and frequent infusion treatment will bring inconvenience to patients. MACBETH study compared the maintenance of bevacizumab with cetuximab, although there was no significant difference in PFS between them, the Bev group seemed to convey a longer median OS. Fruquintinib is a highly selective anti angiogenesis TKI. This study aims to explore the efficacy and safety of fruquintinib combined with capecitabine in maintenance treatment after first-line chemotherapy combined with cetuximab. Both fruquintinib and capecitabine are orally given, so this regimen may provide a maintenance treatment option that is more manageable for patients in clinical practice.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Ⅰb: capecitabine: 1000 mg/m²,PO BID, d1-14,Q3W; fruquintinib 3mg/4mg/5mg, d1-14, PO QD, Q3W. ⅠⅠ: fruquintinib RP2D, d1-14, PO QD, Q3W, capecitabine: 1000 mg/m²,PO BID, d1-14,Q3W
National Center/Cancer Hospital, China Academy of Medical Science and Peking Union Medical College
Beijing, China
RECRUITINGrecommended phase 2 dose (RP2D)
RP2D is determined according to DLT and MTD in the phase 1 study
Time frame: up to 1 year
progression-free survival (PFS)
PFS is defined as the time from the start of maintenance treatment to the earliest evidence of disease progression (per RECIST v1.1), or death from any cause
Time frame: up to 3 years
disease control rate (DCR)
DCR is defined as the proportion of patients achieving complete response, partial response or having stable disease
Time frame: up to 3 years
objective response rate (ORR)
ORR is defined as the proportion of patients achieving complete response or partial response
Time frame: up to 3 years
overall survival (OS)
OS is defined as the time from randomized to death from any cause or to last contact
Time frame: up to 3 years
Adverse events (AEs)
Adverse events assessments are computed and categorized according to the Common Toxicity Criteria of the National Cancer Institute, version 5.0
Time frame: up to 3 years
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