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

6 de dezembro de 2013 atualizado 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).

Visão geral do estudo

Status

Desconhecido

Condições

Intervenção / Tratamento

Descrição detalhada

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 estudo

Intervencional

Inscrição (Antecipado)

120

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 70 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Medicamento: Oxaliplatin
130mg/m2 , iv, 3-4h, d1, 21 d as a cycle.
Outros nomes:
  • L-OHP
Medicamento: Gimeracil and Oteracil Potassium Capsule
40 mg/m2, po., Bid., d1-14, 21 d as a cycle.
Outros nomes:
  • Cápsula Tegafur Gimeracil Oteracil Potássio
Medicamento: Endostar injection
7.5 mg/m2/d, 2 mL/h continuous pumping into vein, d1-10, 21 d as a cycle.
Outros nomes:
  • rh-Endostatin
Comparador Ativo: 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.
Medicamento: Oxaliplatin
130mg/m2 , iv, 3-4h, d1, 21 d as a cycle.
Outros nomes:
  • L-OHP
Medicamento: Gimeracil and Oteracil Potassium Capsule
40 mg/m2, po., Bid., d1-14, 21 d as a cycle.
Outros nomes:
  • Cápsula Tegafur Gimeracil Oteracil Potássio

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Response rate (RR)
Prazo: 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)
Prazo: 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)
Prazo: 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 resultados secundários

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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Tang Xushan

Investigadores

  • Diretor de estudo: Tang Yong, Professor, Cnacer Hospital of Xinjiang Medical University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de agosto de 2013

Conclusão Primária (Antecipado)

1 de maio de 2016

Conclusão do estudo (Antecipado)

1 de agosto de 2016

Datas de inscrição no estudo

Enviado pela primeira vez

27 de novembro de 2013

Enviado pela primeira vez que atendeu aos critérios de CQ

6 de dezembro de 2013

Primeira postagem (Estimativa)

11 de dezembro de 2013

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

11 de dezembro de 2013

Última atualização enviada que atendeu aos critérios de controle de qualidade

6 de dezembro de 2013

Última verificação

1 de agosto de 2013

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • XinjiangMU (006)

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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