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

NCT02008422 | Unknown Phase 3 DMC

• 1 other identifier: XinjiangMU (006)
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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).

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (3)

• 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%;

  The patients were followed up for 3 years.

• 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;

  The patients were followed up for 3 years.

• progression-free survival (PFS)

  PFS was from randomization to tumor progression or death.

  The patients were followed up for 3 years

Secondary Outcomes (1)

• overall survival (OS)

  The patients were followed up for 3 years

Study Arms (2)

Oxaliplatin & Endostar injection

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.

Drug: Oxaliplatin; Drug: Gimeracil and Oteracil Potassium Capsule; Drug: Endostar injection

Oxaliplatin

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.

Drug: Oxaliplatin; Drug: Gimeracil and Oteracil Potassium Capsule

Interventions

Oxaliplatin DRUG

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

Also known as: L-OHP

Oxaliplatin; Oxaliplatin & Endostar injection

Gimeracil and Oteracil Potassium Capsule DRUG

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

Also known as: Tegafur Gimeracil Oteracil Potassium Capsule

Oxaliplatin; Oxaliplatin & Endostar injection

Endostar injection DRUG

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

Also known as: rh-Endostatin

Oxaliplatin & Endostar injection

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tang Xushan: lead

Study Sites (1)

Cancer Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 830011, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Oxaliplatin; gimeracil; potassium oxonate; endostar protein

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Tang Yong, Professor

  Cnacer Hospital of Xinjiang Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Xinjiang Medical University

Study Record Dates

• First Submitted: November 27, 2013
• First Posted: December 11, 2013
• Study Start: August 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: August 1, 2016
• Last Updated: December 11, 2013

Record last verified: 2013-08

Locations

CN (1)