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

6 de diciembre de 2013 actualizado por: Tang Xushan

A Randomized, Open and Control Clinical Study of Endostar Injection Concomitant With SOX Protocols in Treating Advanced Gastric Cancer

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).

Descripción general del estudio

Estado

Desconocido

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

120

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Porcelana
    • Xinjiang
      • Urumqi, Xinjiang, Porcelana, 830011
        • Cancer Hospital of Xinjiang Medical University

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 70 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Droga: Oxaliplatin
130mg/m2 , iv, 3-4h, d1, 21 d as a cycle.
Otros nombres:
  • L-OHP
Droga: Gimeracil and Oteracil Potassium Capsule
40 mg/m2, po., Bid., d1-14, 21 d as a cycle.
Otros nombres:
  • Tegafur Gimeracil Oteracil Potasio Cápsula
Droga: Endostar injection
7.5 mg/m2/d, 2 mL/h continuous pumping into vein, d1-10, 21 d as a cycle.
Otros nombres:
  • rh-Endostatin
Comparador activo: 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.
Droga: Oxaliplatin
130mg/m2 , iv, 3-4h, d1, 21 d as a cycle.
Otros nombres:
  • L-OHP
Droga: Gimeracil and Oteracil Potassium Capsule
40 mg/m2, po., Bid., d1-14, 21 d as a cycle.
Otros nombres:
  • Tegafur Gimeracil Oteracil Potasio Cápsula

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Response rate (RR)
Periodo de tiempo: The patients were followed up for 3 years.
  • 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)
Periodo de tiempo: The patients were followed up for 3 years.
  • 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)
Periodo de tiempo: The patients were followed up for 3 years
PFS was from randomization to tumor progression or death.
The patients were followed up for 3 years

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
overall survival (OS)
Periodo de tiempo: The patients were followed up for 3 years
The patients were followed up for 3 years

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Tang Xushan

Investigadores

  • Director de estudio: Tang Yong, Professor, Cnacer Hospital of Xinjiang Medical University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de agosto de 2013

Finalización primaria (Anticipado)

1 de mayo de 2016

Finalización del estudio (Anticipado)

1 de agosto de 2016

Fechas de registro del estudio

Enviado por primera vez

27 de noviembre de 2013

Primero enviado que cumplió con los criterios de control de calidad

6 de diciembre de 2013

Publicado por primera vez (Estimar)

11 de diciembre de 2013

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

11 de diciembre de 2013

Última actualización enviada que cumplió con los criterios de control de calidad

6 de diciembre de 2013

Última verificación

1 de agosto de 2013

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • XinjiangMU (006)

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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