Advanced Solid Tumors Clinical Trial
Official title:
Phase I/IIa, Single-Arm, Open Study of Apatinib and MASCT in Patients With Advanced Solid Tumors
The study is aimed to evaluate the efficacy and safety of Apatinib and MASCT in patients with advanced solid tumors.
Angiogenesis is a hallmark of cancer, together with vascular endothelial growth factor
(VEGF) as one of the most important angiogenic drivers. Inhibitors targeting the
VEGF/VEGFR-pathway have shown beneficial effects in many cancer patients, but they are
transient and followed by fast regrowth. Similarly, the effectiveness of tumor
immunotherapies has been limited by tumor-mediated escape mechanisms and immune suppression.
By combining the two strategies, antiangiogenic immunotherapy offers the possibility to more
vigorously inhibit tumor angiogenesis and promote an enduring immune-stimulatory milieu that
leads to prolonged survival benefits in cancer patients.
Apatinib is a small-molecule tyrosine kinase inhibitor (TKI) that highly selectively binds
to and strongly inhibits vascular endothelial growth factor receptor 2 (VEGFR-2). Apatinib
has been demonstrated as monotherapy prolongs OS in patients with gastric or
gastroesophageal junction adenocarcinoma after two or more lines of chemotherapy with
moderate, reversible, and easily managed adverse events.
Multiple antigens specific cellular therapy (MASCT) is a new immunotherapy that dendritic
cells(DC) was induced from autologous peripheral blood. The DC can then be loaded with 17
antigens and re-infused. In vitro, antigen-pulsed DC can stimulate autologous T-cell
proliferation and induction of autologous specific cytotoxic T-cells(CTL)，similarly
re-infused. The previous research data showed that MASCT had the modest overall response and
less adverse effects for Hepatocellular Carcinoma patients.
The study is aimed to evaluate the efficacy and safety of Apatinib and MASCT in patients
with advanced solid tumors.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
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