Clinical Study of Endostar Injection Concomitant With SOX Protocols to Treat Advanced Gastric Cancer

• Status: Unknown status
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tang Xushan
• Treatments: Endostar protein; Endostatins; Oxaliplatin; Tegafur

Criteria

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.