- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT03276156
Apatinib in Combination With S-1 as Second-Line Treatment in Patients With Advanced Gastric Cancer
Apatinib in Combination With S-1 as Second-Line Treatment in Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Fase 1
Contactos e Locais
Locais de estudo
-
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Zhejiang
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Hangzhou, Zhejiang, China
- Recrutamento
- Zhejiang Cancer Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Fully informed consent prior to any specific research procedure.
- Adult patients, aged ≥18 years;
Imaging test confirmed the progression after first-line treatment of advanced gastric adenocarcinoma or Gastroesophageal Junction Adenocarcinoma.
- S-1 was not used in the first-line treatment
- If patient relapse in 6 months after adjuvant chemotherapy or neoadjuvant chemotherapy, the adjuvant chemotherapy or neoadjuvant chemotherapy was regarded as the first-line treatment.
- Adjuvant chemotherapy or neoadjuvant chemotherapy was allowed if the first-line treatment started beyond 6 months after the end of previous treatment.
- During the research ,patient should be willing and be able to follow the process treatment ,follow up and tests.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.
- Survival expectation ≥ 16 weeks from the planned first dosing .
- During the 28 days prior to the first dosing, hematological, biochemical and Organ Functions:HB ≥ 9.0 g/dL, ANC ≥ 1.5×109/L,WBC>3×109/L, PLT ≥ 100×109/L, BIL < 1.5×ULN, ALT or AST < 2.5×ULN (or < 5×ULN in patients with liver metastases), Serum Cr ≤ 1.5×ULN;
Lesions ,measurable and/or unmeasurable,at least one,can be assessed by imaging during the baseline and follow-up measurement.
- Localized mass in gastric or Gastroesophageal Junction belongs to unmeasurable Lesions.
Women, those postmenopausal or of child-bearing age, but the pregnancy test results (serum or urine) within 28 days before treatment is negative, and the results should be confirmed in day 1 of the treatment.
- Postmenopausal women are defined as :woman's menstrual periods have ceased for 1 year or longer after exogenous hormone therapy;
- Women, aged>50years,serum LH and FSH level show a postmenopause;
- Woman has radiation induced ovarian failure,and gone without a period for over 12 consecutive months;
- Woman has chemotherapy-induced menopause and gone without a period for over 12 consecutive months;
- sterilization operation( hysterectomy or bilateral oophorectomy)
Exclusion Criteria:
- Has participated in another clinical trial in progress.
- Has received more than one chemotherapy regimens after disease progression(except for those who has receiced adjuvant chemotherapy or neoadjuvant chemotherapy 6 months or longer)
- Previous therapy with S-1
- Has received VEGFR inhibitor, such as Sorafenib,Sunitinib .
- Has another primary tumor,but adequately treated non-melanoma skin cancer , effectively treated carcinoma in situ of cervix and other well handled cancer over 5 years were not covered.
- Has difficulty in swallowing
- Has taken experimental drugs within 14 days before randomly assign.( For different drug characteristics, the interval can be longer)
- History of any chemotherapy, radiotherapy,the last administration should finish within 3 weeks prior to trial first drug administration( For different drug characteristics, the interval can be longer). If steady dose of diphosphate or denosumab is necessary for the treatment of bone metastases,the administration should start 3-4weeks prior to the study .
- Patients with poor-controlled arterial hypertension (systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mm Hg) despite standard medical management; Coronary heart disease greater than Class I, arrhythmia greater than Class I (including QT interval prolongation, for man > 450 ms, for woman > 470 ms), and cardiac dysfunction greater than Class I;
- Has persistent toxicity (exclude alopecia )of previous treatment ,CTCAE>1.
- Has intestinal obstruction or upper gastrointestinal hemorrhage(CTCAE 3 or 4) within 4 weeks prior to randomly assign.
- Abnormal coagulation function (INR > 1.5×ULN, APTT > 1.5×ULN), with tendency of bleed;
- Has symptom of brain metastases and the tendency out of control,but imaging confirmed is not required.If steady dose of Glucocorticoid is necessary for the treatment,the administration should be started >4weeks prior to the study . Patients with spinal cord compression received definite treatment and the situation had been proven stable in 28days .
- Has surgery within 2 weeks prior to the study. Eligible patients should recovered from any major surgery.
- Subjects that are unable to swallow tablets, chronic diarrhea ,or intestinal obstruction;
- Subjects with a clear tendency of gastrointestinal bleeding;
- Pregnant or lactating women;
- Other conditions regimented at investigators' discretion.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: Apatinib plus S-1
Apatinib (425/500/675/750mg,qd,p.o.) concomitantly with S-1 (80mg to 120 mg, qd,days1-14, q3w, p.o.)
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Drug:Apatinib (425 mg/d) + S-1 (80mg to 120 mg);Drug:Apatinib (500 mg/d) + S-1 (80mg to 120 mg);Drug:Apatinib (675mg/d) + S-1 (80mg to 120 mg);Drug:Apatinib (750 mg/d) + S-1 (80mg to 120 mg);
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
Progression Free Survival(PFS)
Prazo: Event driven, an expected average of 4 months
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Event driven, an expected average of 4 months
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Incidence of adverse events
Prazo: An expected average of 4 months
|
An expected average of 4 months
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
---|---|
Overall survival(OS)
Prazo: An expected average of 12months
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An expected average of 12months
|
Disease control rate(DCR)
Prazo: An expected average of 4 months
|
An expected average of 4 months
|
Objective response rate(ORR)
Prazo: An expected average of 4 months
|
An expected average of 4 months
|
Quality of life(QoL)
Prazo: An expected average of 12 months
|
An expected average of 12 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Doenças do aparelho digestivo
- Neoplasias
- Neoplasias por local
- Neoplasias gastrointestinais
- Neoplasias do Aparelho Digestivo
- Doenças Gastrointestinais
- Doenças do Estômago
- Neoplasias do Estômago
- Mecanismos Moleculares de Ação Farmacológica
- Inibidores Enzimáticos
- Agentes Antineoplásicos
- Inibidores de proteína quinase
- Apatinibe
Outros números de identificação do estudo
- Ahead-G001
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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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