Clinical Study of Endostar Injection Concomitant With SOX Protocols to Treat Advanced Gastric Cancer
NCT ID: NCT02008422
Last Updated: 2013-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
120 participants
INTERVENTIONAL
2013-08-31
2016-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Oxaliplatin & Endostar injection
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
130mg/m2 , iv, 3-4h, d1, 21 d as a cycle.
Gimeracil and Oteracil Potassium Capsule
40 mg/m2, po., Bid., d1-14, 21 d as a cycle.
Endostar injection
7.5 mg/m2/d, 2 mL/h continuous pumping into vein, d1-10, 21 d as a cycle.
Oxaliplatin
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
130mg/m2 , iv, 3-4h, d1, 21 d as a cycle.
Gimeracil and Oteracil Potassium Capsule
40 mg/m2, po., Bid., d1-14, 21 d as a cycle.
Interventions
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Oxaliplatin
130mg/m2 , iv, 3-4h, d1, 21 d as a cycle.
Gimeracil and Oteracil Potassium Capsule
40 mg/m2, po., Bid., d1-14, 21 d as a cycle.
Endostar injection
7.5 mg/m2/d, 2 mL/h continuous pumping into vein, d1-10, 21 d as a cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
70 Years
ALL
No
Sponsors
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Tang Xushan
OTHER
Responsible Party
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Tang Xushan
Xinjiang Medical University
Principal Investigators
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Tang Yong, Professor
Role: STUDY_DIRECTOR
Cnacer Hospital of Xinjiang Medical University
Locations
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Cancer Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
Countries
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Other Identifiers
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XinjiangMU (006)
Identifier Type: -
Identifier Source: org_study_id