Overview

This trial is active, not recruiting.

Condition gastric cancer
Treatments oxaliplatin, gimeracil and oteracil potassium capsule, endostar injection
Phase phase 3
Sponsor Tang Xushan
Start date August 2013
End date May 2016
Trial size 120 participants
Trial identifier NCT02008422, XinjiangMU (006)

Summary

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Oxaliplatin, 130 mg/m2 , iv, 3-4h, d1; Gimeracil and Oteracil Potassium Capsules, 40 mg/m2, po., Bid., d1-14; Endostar injection, 7.5 mg/m2/d, 2 mL/h continuous pumping into vein, d1-10; 21 d as a cycle.
oxaliplatin L-OHP
130mg/m2 , iv, 3-4h, d1, 21 d as a cycle.
gimeracil and oteracil potassium capsule Tegafur Gimeracil Oteracil Potassium Capsule
40 mg/m2, po., Bid., d1-14, 21 d as a cycle.
endostar injection rh-Endostatin
7.5 mg/m2/d, 2 mL/h continuous pumping into vein, d1-10, 21 d as a cycle.
(Active Comparator)
Oxaliplatin, 130 mg/m2 , iv, 3-4h, d1; Gimeracil and Oteracil Potassium Capsules, 40 mg/m2, po., Bid., d1-14, 21 d as a cycle.
oxaliplatin L-OHP
130mg/m2 , iv, 3-4h, d1, 21 d as a cycle.
gimeracil and oteracil potassium capsule Tegafur Gimeracil Oteracil Potassium Capsule
40 mg/m2, po., Bid., d1-14, 21 d as a cycle.

Primary Outcomes

Measure
Response rate (RR)
time frame: The patients were followed up for 3 years.
clinical benefit rate (CBR)
time frame: The patients were followed up for 3 years.
progression-free survival (PFS)
time frame: The patients were followed up for 3 years

Secondary Outcomes

Measure
overall survival (OS)
time frame: The patients were followed up for 3 years

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: - Age: 18~70 years; - Performance status (PS) of Eastern Cooperative Oncology Group (ECOG) was 0~1 or KPS scores were 60-100 scores; - Patients who were diagnosed with recurrent and metastatic advanced gastric cancer by histopathology and CT; - Patients who had more than 1 measurable nidus (common CT or MRI scanning ≥20 mm, spiral CT scanning ≥10 mm); - Patients who had no severe dysfunction of important organs, and were normal in blood routine test, hepatorenal function, electrolytes and cardiac function, with white blood cell count≥4.0×109/L, neutrophil count≥1.5×109/L, platelet count≥100×109/L, hemoglobin≥95g/L, serum bilirubin≤1.5 folds of upper normal limit, Alanine transaminase and glutamic oxalacetic transaminase ≤2 folds of upper normal limit, and serum creatinine≤1.5mg/dl. - Estimated survival time was above 3 months; - Patients who were well acknowledged of this study and signed the informed consent forms. Exclusion Criteria: - Patients who received whole body treatment of metastatic gastric cancer previously; - Patients who underwent surgeries within 4 weeks before this study; - Patients who had allergic constitutions or were allergic to biological products of proteins and to any medicine used in this study; - Female patients in gestation or lactation period, or those who were interfile but received no contraception measures; - Patients who were with other symptoms unsuitable to this study; - Patients who were treated by other anti-tumor methods at that time; - Patients who had no measurable nidus; - Patients who had one of the following conditions: uncontrolled metastatic nidus in central nervous system, dysfunction of important organs, severe cardiac diseases (including congestive heart failure, uncontrollable arrhythmia, angina pectoris needed long-term drug treatment, valvular heart diseases and myocardial infarction), hypertension, women in gestation or lactation period, protracted infectious wound as well as uncontrollable psychosis history.

Additional Information

Official title A Randomized, Open and Control Clinical Study of Endostar Injection Concomitant With SOX Protocols in Treating Advanced Gastric Cancer
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by Xinjiang Medical University.