Back to resultsClinical Study of Endostar Injection Concomitant With SOX Protocols to Treat Advanced Gastric Cancer
Primary Purpose
Gastric Cancer
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Oxaliplatin
Gimeracil and Oteracil Potassium Capsule
Endostar injection
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer
Eligibility 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.
Sites / Locations
- Cancer Hospital of Xinjiang Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Oxaliplatin & Endostar injection
Oxaliplatin
Arm Description
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, 130 mg/m2 , iv, 3-4h, d1; Gimeracil and Oteracil Potassium Capsules, 40 mg/m2, po., Bid., d1-14, 21 d as a cycle.
Outcomes
Primary Outcome Measures
Response rate (RR)
Clinical RR=(CR＋PR)/total cases×100%;
Complete remission (CR): all visible nidi disappeared;
Partial remission (PR): the decreased total length of diameter of baseline nidus≥30%;
clinical benefit rate (CBR)
Clinical CBR＝(CR＋PR＋SD)/total cases×100%
Complete remission (CR): all visible nidi disappeared;
Stable disease (SD): the total length of diameter of baseline nidus decreased<that in PR or increased <that in PD.-Progressive disease (PD): the increased total length of diameter of baseline nidus≥30% or new nidus was presented;
progression-free survival (PFS)
PFS was from randomization to tumor progression or death.
Secondary Outcome Measures
overall survival (OS)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02008422
Brief Title
Clinical Study of Endostar Injection Concomitant With SOX Protocols to Treat Advanced Gastric Cancer
Official Title
A Randomized, Open and Control Clinical Study of Endostar Injection Concomitant With SOX Protocols in Treating Advanced Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
August 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Tang Xushan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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).
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Oxaliplatin & Endostar injection
Arm Type
Experimental
Arm Description
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.
Arm Title
Oxaliplatin
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Other Intervention Name(s)
L-OHP
Intervention Description
130mg/m2 , iv, 3-4h, d1, 21 d as a cycle.
Intervention Type
Drug
Intervention Name(s)
Gimeracil and Oteracil Potassium Capsule
Other Intervention Name(s)
Tegafur Gimeracil Oteracil Potassium Capsule
Intervention Description
40 mg/m2, po., Bid., d1-14, 21 d as a cycle.
Intervention Type
Drug
Intervention Name(s)
Endostar injection
Other Intervention Name(s)
rh-Endostatin
Intervention Description
7.5 mg/m2/d, 2 mL/h continuous pumping into vein, d1-10, 21 d as a cycle.
Primary Outcome Measure Information:
Title
Response rate (RR)
Description
Clinical RR=(CR＋PR)/total cases×100%;
Complete remission (CR): all visible nidi disappeared;
Partial remission (PR): the decreased total length of diameter of baseline nidus≥30%;
Time Frame
The patients were followed up for 3 years.
Title
clinical benefit rate (CBR)
Description
Clinical CBR＝(CR＋PR＋SD)/total cases×100%
Complete remission (CR): all visible nidi disappeared;
Stable disease (SD): the total length of diameter of baseline nidus decreased<that in PR or increased <that in PD.-Progressive disease (PD): the increased total length of diameter of baseline nidus≥30% or new nidus was presented;
Time Frame
The patients were followed up for 3 years.
Title
progression-free survival (PFS)
Description
PFS was from randomization to tumor progression or death.
Time Frame
The patients were followed up for 3 years
Secondary Outcome Measure Information:
Title
overall survival (OS)
Time Frame
The patients were followed up for 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tang Yong, Professor
Organizational Affiliation
Cnacer Hospital of Xinjiang Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Cancer Hospital of Xinjiang Medical University
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830011
Country
China
12. IPD Sharing Statement
Learn more about this trial
Clinical Study of Endostar Injection Concomitant With SOX Protocols to Treat Advanced Gastric Cancer
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