Apatinib Versus Bevacizumab in Second-line Therapy for Colorectal Cancer(ABST-C)
Status:
Recruiting
Trial end date:
2022-12-31
Target enrollment:
Participant gender:
Summary
Bevacizumab, as an antibody of vascular endothelial generated factor (VEGF), combined with
the fluorouracil-based chemotherapy regimens for metastatic colorectal cancer, has become the
classical first-line treatment. However, vast majority of patients eventually will suffer
progression disease. The second-line treatment includes replacing chemotherapy regimens
whistle continuing bevacizumab or other anti-VEGF antibodies, such as Aflibercept and
Ramucirumab. Apatinib is a small molecule tyrosine kinase inhibitor (TKI), which can highly
selectively bind to and strongly block VEGF receptor 2 (VEGFR - 2), also potently suppress
the activities of Ret, c-kit and c-src, resulting in reduced cell migration, proliferation,
and tumor microvascular density mediated by VEGF .There are already robust data showing that
antibodies aimed at blocking VEGF signaling pathways combined with chemotherapy to treat
advanced colorectal cancer is superior as compared to chemotherapy alone. Thus, we
hypothesize that the effect of using the second-line chemotherapy regimens combined with
apatinib may be superior to those combined with bevacizumab. In this study,the patients who
have progressed following or on first-line oxaliplatin and 5-FU combined with bevacizumab are
randomised into two arms. Patients in the experimental arm receive second-line FOLFIRI
combined with apatinib and those in the control arm receive second-line FOLFIRI combined with
bevacizumab. To compare the efficacy and safety of the two arms, progression-free
survival(PFS) is the primary end point.If apatinib is superior to bevacizumab in the
second-line setting,it is one possible option of anti-angiogenic therapy in combination with
second-line FOLFIRI for treatment of advanced colorectal cancer.