MedTrace Logo

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

NCT02008422 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2013-12-11

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Oxaliplatin

130mg/m2 , iv, 3-4h, d1, 21 d as a cycle.

DRUG

Gimeracil and Oteracil Potassium Capsule

40 mg/m2, po., Bid., d1-14, 21 d as a cycle.

DRUG

Endostar injection

7.5 mg/m2/d, 2 mL/h continuous pumping into vein, d1-10, 21 d as a cycle.

Sponsors & Collaborators

  • Tang Xushan

    lead OTHER

Principal Investigators

  • Tang Yong, Professor · Cnacer Hospital of Xinjiang Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2016-05-31
Completion
2016-08-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02008422 on ClinicalTrials.gov