Gastric Cancer Clinical Trial
Official title:
A Randomized, Open and Control Clinical Study of Endostar Injection Concomitant With SOX Protocols in Treating Advanced Gastric Cancer
The primary objectives of this control, single-center clinical study of EndostarTM Injection with/without SOX protocols to treat advanced gastric cancer were to evaluate the clinical response rate of Endostar injection concomitant with SOX on patients with advanced gastric cancer, observe the progression-free survival time (PFS) of tumor and evaluate the safety and tolerance of Endostar injection, while the secondary objectives were to observe the influence of Endostar injection on chemotherapy-induced adverse reactions and evaluate the overall survival time of EndostarTM injection concomitant with SOX on patients with advanced gastric cancer by evaluating the response rate (RR) clinical benefit rate (CBR), progression-free survival (PFS) and overall survival (OS).
Multiple pre-clinical studies have indicated that in dozens of animal tumor models and human
tumor-metastatic mice tumor models, the effective rate of Endostar was 47%～91% in daily
dosage of 10～100mg/kg, and covered human commonly seen malignant tumors, such as lung
cancer, gastric cancer, breast cancer, colorectal cancer, hepatic cancer, malignant melanoma
and non-Hodgkin's lymphoma, etc.. The development and progression of gastric cancer was in
association with angiogenesis. An animal research observed the influence of Endostar on
tumor strains in nude mice with gastric cancer, and the results showed that tumor size
shrunk rapidly and the expressions of VEGF, bFGF, VEGF-C, VEGFR-3, bcl-2 and PDGF decreased
significantly after treatment in experimental group, demonstrating that Endostar could
reduce angiogenesis, increase tumor cell apoptosis and inhibit tumor growth in gastric
cancer. An investigation of small-sample Endostar concomitant with chemotherapy on patients
with advanced gastric cancer primarily indicated the efficacy and feasibility of Endostar
concomitant with chemotherapy in treating gastric cancer.
With the expanded application of Endostar in clinic, it also obtains certain effect in
treating patients with lung cancer and colorectal cancer. The safety, efficacy, evaluation
of relationship between benefit and risk in common or special population as well as the
modified dosage of administration of Endostar in wide application should be further explored
to provide sufficient scientifical basis for the safety, efficacy, applicable rule in
special population and investigation of optimal administrative protocols for Endostar in
wide application.
This control, single-center clinical study of EndostarTM Injection with/without SOX
protocols to treat advanced gastric cancer was conducted to explore the feasibility,
efficacy and safety of Endostar concomitant with SOX protocols, and to provide more
evidence-based medical basis for the clinical application of Endostar.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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